Zephrex LA Sustained-Release Tablets

Pronunciation: gwye-FEN-ah-sin/sue-do-eh-FED-rin
Generic Name: Guaifenesin/Pseudoephedrine
Brand Name: Examples include Entex PSE and Zephrex LA

Zephrex LA Sustained-Release Tablets are used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Zephrex LA Sustained-Release Tablets are a decongestant and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Zephrex LA Sustained-Release Tablets if:

• you are allergic to any ingredient in Zephrex LA Sustained-Release Tablets


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zephrex LA Sustained-Release Tablets:

Some medical conditions may interact with Zephrex LA Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate, seizures, or an overactive thyroid


• if you have chronic cough

Some MEDICINES MAY INTERACT with Zephrex LA Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Zephrex LA Sustained-Release Tablets's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by Zephrex LA Sustained-Release Tablets


• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Zephrex LA Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zephrex LA Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zephrex LA Sustained-Release Tablets:

Use Zephrex LA Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Zephrex LA Sustained-Release Tablets by mouth with or without food.


• Take Zephrex LA Sustained-Release Tablets with a full glass of water (8 oz/240 mL) unless your doctor tells you otherwise.


• If you miss a dose of Zephrex LA Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zephrex LA Sustained-Release Tablets.

Important safety information:

• Zephrex LA Sustained-Release Tablets may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Zephrex LA Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take appetite suppressants while you are taking Zephrex LA Sustained-Release Tablets without checking with your doctor.


• Zephrex LA Sustained-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Zephrex LA Sustained-Release Tablets may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Zephrex LA Sustained-Release Tablets.


• Tell your doctor or dentist that you take Zephrex LA Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Use Zephrex LA Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Zephrex LA Sustained-Release Tablets in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Zephrex LA Sustained-Release Tablets, contact your doctor. You will need to discuss the benefits and risks of using Zephrex LA Sustained-Release Tablets while pregnant. It is not known if Zephrex LA Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Zephrex LA Sustained-Release Tablets.

Possible side effects of Zephrex LA Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zephrex LA side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Zephrex LA Sustained-Release Tablets:

Store Zephrex LA Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zephrex LA Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Zephrex LA Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Zephrex LA Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zephrex LA Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zephrex LA resources

• Zephrex LA Side Effects (in more detail)
• Zephrex LA Use in Pregnancy & Breastfeeding
• Zephrex LA Drug Interactions
• Zephrex LA Support Group
• 0 Reviews for Zephrex LA - Add your own review/rating

Compare Zephrex LA with other medications

• Cough and Nasal Congestion

Aquacillin

Dosage Form: FOR ANIMAL USE ONLY
Drug Facts

Description General Information

Procaine penicillin G is a potent antibacterial agent which is effective against a variety of pathogenic organisms, chiefly in the Gram-positive category. Aquacillin is a free-flowing product prepared by combining penicillin G and procaine, molecule for molecule, with dispersing agents.

Residue Warnings

RESIDUE WARNINGS: (FDA Requested Revision) 100mL & 250mL-Label

Milk taken from animals during treatment and for 48 hours (4 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.

RESIDUE WARNINGS:(FDA Requested Revision) 100mL & 250mL-Onsert

Milk that has been taken from animals during treatment and for 48 hours (4 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.

WARNING: (Old revision) 500mL-Label

Milk taken from animals during treatment and for 48 hours (4 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in veal calves.

Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.

WARNING: (Old revision) 500mL-Onsert

Milk that has been taken from animals during treatment and for 48 hours (4 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in veal calves.

Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.

Aquacillin is a registered trademark of VEDCO, Inc.

LOT

EXP DATE

760001

Directions for Use

Aquacillin should be administered by the intramuscular route. A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized by boiling in water for 15 minutes). Before withdrawing the solution from the bottle, disinfect the rubber cap on the bottle with a suitable disinfectant such as 70 percent alcohol. The injection site should be similarly cleaned with the disinfectant. Needles of 16 to 18 gauge and 1 to 1½ inches long are adequate for intramuscular injection.

INTRAMUSCULAR INJECTION: In livestock, intramuscular injection should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle such as the rump, hip, or thigh region; avoid blood vessels and major nerves. Before injecting the solution, pull back gently on the plunger. If blood appears in the syringe, a blood vessel has been entered; withdraw the needle and select a different site. No more than 10mL should be injected at any one site in adult livestock; rotate injection sites for each succeeding treatment.

Care of sick animals: The use of antibiotics in the management of disease is based on an accurate diagnosis and an adequate course of treatment. When properly used in the treatment of diseases caused by penicillin-susceptible organisms. Most animals treated with Aquacillin show a noticeable improvement within 24 to 48 hours. If improvement does not occur within this period of time, the diagnosis and course of treatment should be re-evaluated. It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian. Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, cost, and needless losses. Good housing, sanitation, and nutrition are important in the maintenance of healthy animals and are essential in the treatment of disease

Contains

Each mL of Aquacillin contains 300,000 units of procaine penicillin G and approximately: 0.08% sodium citrate; 0.15% sodium carboxymethylcellulose; 25% sorbitol solution; 0.06% povidone; 0.6% lecithin; 0.1% methylparaben; 0.01% propylparaben; 0.25% phenol.

Store between 2°-8°C (36°-46°F)

Restricted Drug (California)

Refer to package insert for complete directions.

 SHAKE WELL BEFORE USING.

Manufactured for VEDCO, Inc.

Manufactured By Teva Animal Health, Inc. Fort Dodge, IA 50501

Front Panel Label

Aquacillin

Penicillin-G Procaine In Aqueous Suspension

Injectable Antibiotic

For the treatment of disease in cattle, swine, sheep and horses.

For Intramuscular Use Only.

NOT FOR HUMAN USE

USE ONLY AS DIRECTED

NADA 65-110, Approved by FDA

Indications

INDICATIONS: (FDA Requested Revision) 100mL & 250mL-label

Aquacillin is recommended for treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida in cattle and sheep, erysipelas caused by Erysipelothrix rhusiopathiae in swine, and strangles caused by streptococcus equi in horses.

INDICATIONS: (Old reversion) 500mL-label

Aquacillin is recommended for treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida in cattle and sheep, erysipelas caused by Erysipelothrix insidiosa in swine, and strangles caused by streptococcus equi in horses.

DOSAGE LEVELS: The recommended daily dosage of penicillin is 3,000 units per pound of body weight (one mL per 100lb body weight). Continue daily treatment until recovery is apparent and for at least 1 day after symptoms disappear, usually in 2 or 3 days. Treatment should not exceed 4 consecutive days.

Precautions

Exceeding the highest recommended daily dosage of 3,000 units per pound of body weight, administering at recommended levels for more than 4 consecutive days, and/or exceeding 10mL intramuscularly per injection site may result in antibiotic residues beyond the withdrawal time.

Aquacillin should be injected deep within the fleshy muscles of the hip, rump, round, or thigh. Do not inject this material subcutaneously (under the skin), into a blood vessel, or near a major nerve.

Procaine penicillin G is a substance of low toxicity. However, side effects, or so-called allergic or anaphylactic reactions-sometimes fatal, have been known to occur in animals hypersensitive to penicillin and procaine. Such reactions can occur unpredictably with varying intensity. Animals administered Aquacillin should be kept under close observation for at least one-half hour. Should allergic or anaphylactic reactions occur, discontinue use of the product and immediately administer epinephrine following manufacturer’s recommendations; call a veterinarian. As with all antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. A lack of response by the treated animal, or the development of new signs or symptoms suggest that an overgrowth of non-susceptible organisms has occurred. In such instances, consult your veterinarian. Since bactericidal drugs may interfere with the bacteriostatic action of tetracyclines, it is advisable to avoid giving penicillin in conjunction with tetracyclines. Penicillin-G should be stored between 2-8°C (36-46°F). Warm to room temperature and shake before using.

Directions

A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized by boiling in later for 15 minutes). Before withdrawing the solution from the bottle, disinfect the rubber cap on the bottle with a suitable disinfectant such as 70 percent alcohol. The injection site should be similarly cleaned with the disinfectant. Needles of 16 to 18 gauge and not more than 1 to 1½ inch long are adequate for injections.

A subcutaneous injection should be made by pinching up a fold of the skin between the thumb and forefinger. The mid-neck region is the preferred injection site. Insert the needle under the fold in a direction approximately parallel to the surface of the body. When the needle is inserted in this manner the medication will be delivered underneath the skin between the skin and the muscles. Proper restraint, such as the use of a chute and nose lead, is needed for proper administration of the product.

SHAKE WELL BEFORE USING

FOR ANIMAL USE ONLY

RESTRICTED DRUG (CALIFORNIA)

USE ONLY AS DIRECTED

NOT FOR HUMAN USE

Storage

Store between 2°-8°C (36°-46°F)

Restricted Drug (California)-Use Only As Directed

Refer to label insert for complete directions.

SHAKE WELL BEFORE USING.

760001-

Rev

Manufactured By Teva Animal Health, Inc. Fort Dodge, IA 50501

Package Information

Aquacillin available in vials of 100mL, 250mL and 500mL with each mL containing 300,000 units of procaine penicillin G. The 500mL vial is intended for use with automatic syringes

FOR ANIMAL USE ONLY

RESTRICTED DRUG (California)

USE ONLY AS DIRECTED.

NOT FOR HUMAN USE.

Principle Display Panel

Principle Display Panel

Principle Display Panel

Aquacillin  penicillin g procaine  injection, suspension

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50989-660 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIN G PROCAINE (PENICILLIN G) PENICILLIN G PROCAINE 300000 ug  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50989-660-12 100 mL In 1 BOTTLE, GLASS None 2 50989-660-15 250 mL In 1 BOTTLE, GLASS None 3 50989-660-16 500 mL In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA65110	07/18/2003	07/31/2009

Labeler - Vedco, Inc. (021634266)

Revised: 02/2010Vedco, Inc.

Gynazole-1 Cream

Pronunciation: byoo-toe-KOE-na-zole
Generic Name: Butoconazole
Brand Name: Gynazole-1

Gynazole-1 Cream is used for:

Treating vaginal yeast infections.

Gynazole-1 Cream is an antifungal agent. It works by weakening the cell wall of sensitive fungi, causing the cell contents to leak. This kills the fungi.

Do NOT use Gynazole-1 Cream if:

• you are allergic to any ingredient in Gynazole-1 Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Gynazole-1 Cream:

Some medical conditions may interact with Gynazole-1 Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Gynazole-1 Cream. However, no specific interactions with Gynazole-1 Cream are known at this time.

Ask your health care provider if Gynazole-1 Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gynazole-1 Cream:

Use Gynazole-1 Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gynazole-1 Cream is for vaginal use only. Do not use in the eyes or take by mouth.


• Wash your hands before and after using Gynazole-1 Cream. Insert 1 applicator-full of cream into the vagina. Throw the applicator away after using it.


• Only one dose of Gynazole-1 Cream is required. If you forget to use Gynazole-1 Cream, use it as soon as you remember.

Ask your health care provider any questions you may have about how to use Gynazole-1 Cream.

Important safety information:

• If your symptoms do not get better within a few days or if they get worse, check with your doctor.


• If your infection clears up and occurs again in a few weeks, see your doctor. Recurrent vaginal infections, especially those that are difficult to cure, may be an early sign of HIV infection in women who are considered at risk for HIV infection.


• Gynazole-1 Cream may be used during your period. Use a sanitary pad rather than a tampon to prevent staining of clothing.


• Gynazole-1 Cream contains mineral oil, which may weaken latex or rubber products such as condoms and diaphragms. Do not use condoms or diaphragms within 72 hours of using Gynazole-1 Cream.


• Gynazole-1 Cream should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gynazole-1 Cream while you are pregnant. It is not known if Gynazole-1 Cream is found in breast milk. If you are or will be breast-feeding while you use Gynazole-1 Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gynazole-1 Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning, itching, soreness, or swelling in or around the vagina not present before using Gynazole-1 Cream.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); pain or cramping in the stomach or pelvic area.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Gynazole-1 side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Gynazole-1 Cream may be harmful if swallowed.

Proper storage of Gynazole-1 Cream:

Store Gynazole-1 Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Gynazole-1 Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Gynazole-1 Cream, please talk with your doctor, pharmacist, or other health care provider.


• Gynazole-1 Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Gynazole-1 Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Gynazole-1 resources

• Gynazole-1 Side Effects (in more detail)
• Gynazole-1 Use in Pregnancy & Breastfeeding
• Gynazole-1 Support Group
• 2 Reviews for Gynazole-1 - Add your own review/rating

Compare Gynazole-1 with other medications

• Vaginal Yeast Infection

Erythromycin/Sulfisoxazole

Pronunciation: e-RITH-roe-MYE-sin/SUL-fi-SOX-a-zole
Generic Name: Erythromycin/Sulfisoxazole
Brand Name: E.S.P.

Erythromycin/Sulfisoxazole is used for:

Treating ear infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Erythromycin/Sulfisoxazole is a macrolide and sulfonamide antibiotic combination. It works by slowing the growth of and killing sensitive bacteria.

Do NOT use Erythromycin/Sulfisoxazole if:

• you are allergic to any ingredient in Erythromycin/Sulfisoxazole or to any other sulfonamide medicine (eg, sulfamethoxazole)


• you are pregnant and at term (38 to 42 weeks)


• you are breast-feeding a child younger than 2 months old


• the patient is a child younger than 2 months old


• you have severe kidney problems, bladder blockage, or anemia caused by folic acid deficiency


• you are taking astemizole, cisapride, diltiazem, dofetilide, dronedarone, eletriptan, an ergot alkaloid (eg, dihydroergotamine, ergotamine), halofantrine, an HIV protease inhibitor (eg, ritonavir), an imidazole (eg, ketoconazole), nilotinib, pimozide, propafenone, a streptogramin (eg, quinupristin/dalfopristin), terfenadine, tetrabenazine, tolvaptan, toremifene, vandetanib, or verapamil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Erythromycin/Sulfisoxazole:

Some medical conditions may interact with Erythromycin/Sulfisoxazole. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diarrhea or throat inflammation


• if you have a history of asthma, blood problems, a glucose-6-phosphate dehydrogenase (G6PD) deficiency, kidney or liver problems, heart problems, a fast or irregular heartbeat, myasthenia gravis, or the blood disease porphyria


• if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Erythromycin/Sulfisoxazole. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Astemizole, cisapride, diltiazem, dofetilide, dronedarone, halofantrine, an HIV protease inhibitor (eg, ritonavir), an imidazole (eg, ketoconazole), nilotinib, pimozide, propafenone, a streptogramin (eg, quinupristin/dalfopristin), terfenadine, tetrabenazine, toremifene, vandetanib, or verapamil because side effects, such as heart toxicity or irregular heartbeat, may occur. Check with your doctor if you have questions about which medicines may affect your heartbeat


• Eletriptan, ergot alkaloids (eg, dihydroergotamine, ergotamine), or tolvaptan because the risk of their side effects may be increased by Erythromycin/Sulfisoxazole


• Many prescription and nonprescription medicines (eg, used for aches and pains, allergies, blood thinning, breathing problems, cancer, diabetes, erection problems, gout, irregular heartbeat or other heart problems, high blood calcium levels, high blood pressure, high cholesterol, HIV infection, inflammation, infections, low blood sodium levels, migraine, mood or mental problems, nausea and vomiting, overactive bladder, Parkinson disease, prevention of organ transplant rejection, seizures, stomach problems, trouble sleeping), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may also interact with Erythromycin/Sulfisoxazole. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with Erythromycin/Sulfisoxazole

This may not be a complete list of all interactions that may occur. Ask your health care provider if Erythromycin/Sulfisoxazole may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Erythromycin/Sulfisoxazole:

Use Erythromycin/Sulfisoxazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Erythromycin/Sulfisoxazole by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Drinking extra fluids while you are taking Erythromycin/Sulfisoxazole is recommended. Check with your doctor for instructions.


• Do not eat grapefruit or drink grapefruit juice while you use Erythromycin/Sulfisoxazole.


• Erythromycin/Sulfisoxazole works best if it is taken at the same time(s) each day.


• To clear up your infection completely, take Erythromycin/Sulfisoxazole for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Erythromycin/Sulfisoxazole, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Erythromycin/Sulfisoxazole.

Important safety information:

• Erythromycin/Sulfisoxazole may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Erythromycin/Sulfisoxazole with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Erythromycin/Sulfisoxazole only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Erythromycin/Sulfisoxazole for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Erythromycin/Sulfisoxazole may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Infrequently, a serious stomach problem called infantile hypertrophic pyloric stenosis (IHPS) has been reported in infants taking erythromycin. Contact your child's doctor right away if severe vomiting or irritability with feeding occurs.


• Tell your doctor or dentist that you take Erythromycin/Sulfisoxazole before you receive any medical or dental care, emergency care, or surgery.


• Rarely, patients taking Erythromycin/Sulfisoxazole have developed reversible hearing loss. This risk is greater if you have kidney problems or you take high doses of Erythromycin/Sulfisoxazole. Contact your doctor if you develop decreased hearing or hearing loss.


• Erythromycin/Sulfisoxazole may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Erythromycin/Sulfisoxazole. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Erythromycin/Sulfisoxazole may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Erythromycin/Sulfisoxazole.


• Lab tests, including liver function, kidney function, complete blood counts, and urinalysis, may be performed while you use Erythromycin/Sulfisoxazole. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Erythromycin/Sulfisoxazole should not be used in CHILDREN younger than 2 months; safety and effectiveness in these children have not been confirmed.


• Use Erythromycin/Sulfisoxazole with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat (prolonged QT interval).


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Erythromycin/Sulfisoxazole while you are pregnant. Do not take Erythromycin/Sulfisoxazole if you are pregnant and at term (38 to 42 weeks). Erythromycin/Sulfisoxazole is found in breast milk. Do not breast-feed while taking Erythromycin/Sulfisoxazole.

Possible side effects of Erythromycin/Sulfisoxazole:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; loss of appetite; mild diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or dark urine; bloody stools; change in the amount of urine; decreased hearing or hearing loss; fainting; fast or irregular heartbeat; fever, chills, or sore throat; mood or mental changes; numbness or tingling of the hands or feet; pale skin; red, swollen, blistered, or peeling skin; ringing in the ear; seizures; severe or persistent diarrhea, dizziness, or headache; severe stomach pain; stomach cramps; shortness of breath; sore mouth or tongue; symptoms of liver problems (eg, yellowing of skin or eyes; pale stools; severe or persistent nausea, vomiting, or loss of appetite; dark urine); unusual bruising or bleeding; unusual weakness or fatigue; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Erythromycin/Sulfisoxazole side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blood in the urine; high fever; loss of consciousness; severe or persistent loss of appetite; severe nausea, dizziness, drowsiness, headache, or vomiting.

Proper storage of Erythromycin/Sulfisoxazole:

Store Erythromycin/Sulfisoxazole in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away any unused medicine after 14 days. Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Keep Erythromycin/Sulfisoxazole out of the reach of children and away from pets.

General information:

• If you have any questions about Erythromycin/Sulfisoxazole, please talk with your doctor, pharmacist, or other health care provider.


• Erythromycin/Sulfisoxazole is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Erythromycin/Sulfisoxazole. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Erythromycin/Sulfisoxazole resources

• Erythromycin/Sulfisoxazole Side Effects (in more detail)
• Erythromycin/Sulfisoxazole Use in Pregnancy & Breastfeeding
• Erythromycin/Sulfisoxazole Drug Interactions
• Erythromycin/Sulfisoxazole Support Group
• 0 Reviews for Erythromycin/Sulfisoxazole - Add your own review/rating

Compare Erythromycin/Sulfisoxazole with other medications

• Otitis Media

Ibuprofen and Diphenhydramine

Dosage Form: tablet
Ibuprofen and Diphenhydramine Citrate Tablets

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPLET*)

Diphenhydramine citrate USP, 38 mg

Ibuprofen USP, 200 mg (NSAID)**

* capsule-shaped tablets

**nonsteroidal anti-inflammatory drug

PURPOSES

Nighttime sleep-aid

Pain reliever

USES

• for relief of occasional sleeplessness when associated with minor aches and pains


• helps you fall asleep and stay asleep

Warnings

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives


• facial swelling


• asthma (wheezing)


• shock


• skin reddening


• rash


• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

• are age 60 or older


• have had stomach ulcers or bleeding problems


• take a blood thinning (anticoagulant) or steroid drug


• take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]


• have 3 or more alcoholic drinks every day while using this product


• take more or for a longer time than directed

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer


• unless you have time for a full night's sleep


• in children under 12 years of age


• right before or after heart surgery


• with any other product containing diphenhydramine, even one used on skin


• if you have sleeplessness without pain.

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis


• problems or serious side effects from taking pain relievers or fever reducers


• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain


• ulcers


• bleeding problems


• high blood pressure


• heart or kidney disease


• asthma


• taken a diuretic


• reached age 60 or older


• glaucoma


• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers, or any other sleep-aid


• taking any other drug containing an NSAID (prescription or nonprescription)


• under a doctor’s care for any continuing medical illness


• taking any other antihistamines


• taking a blood thinning (anticoagulant) or steroid drug


• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin


• taking any other drug

When using this product

• drowsiness will occur


• avoid alcoholic drinks


• do not drive a motor vehicle or operate machinery


• take with food or milk if stomach upset occurs


• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding


• pain gets worse or lasts more than 10 days


• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.


• stomach pain or upset gets worse or lasts


• redness or swelling is present in the painful area


• any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• do not take more than directed


• do not take longer than 10 days, unless directed by a doctor (see WARNINGS)


• adults and children 12 years and over: take 2 caplets at bedtime.


• do not take more than 2 caplets in 24 hours

OTHER INFORMATION

• read all warnings and directions before use. Keep carton.


• store at 20-25°C (68-77°F)


• avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS

carnauba wax, corn starch, colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2, hypromelllose, microcrystalline cellulose, polydextrose, polyethylene glycol 400, pregelatinized starch, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS OR COMMENTS?

Call 1-888-375-3784

Do Not Use if foil seal under bottle cap imprinted with“SEALED for YOUR PROTECTION”  is broken or missing.

Manufactured for:Dr. Reddy’s Laboratories Limited Bachepalli – 502 325 INDIA.

PRINCIPAL DISPLAY PANEL

Pouch label:

DR. REDDY'S

NDC 55111-565-92

Count :2,500 Tablets

Ibuprofen Diphenhydramine Citrate Tablets 200 mg/38 mg

Batch No. :

Mfg. Date :

Repack Before :

Expiration Date :

Store at 20°-25°C (68°-77°F)

Avoid excessive heat above 40°C (104°F).

For Repackaging only.

DO NOT OPEN POUCHES UNTIL REPACKAGING

Mfd. by : Dr. Reddy's Laboratories Limited

Bachepalli - 502 325 INDIA.

Container:

Carton:

Pouch Label:

Ibuprofen and Diphenhydramine CITRATE  Ibuprofen and Diphenhydramine citrate  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 55111-565 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ibuprofen (ibuprofen) ibuprofen 200 mg diphenhydramine citrate (diphenhydramine) diphenhydramine 38 mg

Inactive Ingredients Ingredient Name Strength carnauba wax   STARCH, CORN   colloidal silicon dioxide   croscarmellose sodium   FD&C blue no. 2   CELLULOSE, MICROCRYSTALLINE   HYPROMELLOSE   polydextrose   polyethylene glycol 400   sodium lauryl sulfate   stearic acid   titanium dioxide

Product Characteristics Color BLUE (blue) Score no score Shape CAPSULE (slightly glossy smooth blue film coated) Size 15mm Flavor Imprint Code RDY;565 Contains

Packaging # NDC Package Description Multilevel Packaging 1 55111-565-14 1 BOTTLE In 1 CARTON contains a BOTTLE 1 20 TABLET In 1 BOTTLE This package is contained within the CARTON (55111-565-14) 2 55111-565-30 1 BOTTLE In 1 CARTON contains a BOTTLE 2 30 TABLET In 1 BOTTLE This package is contained within the CARTON (55111-565-30) 3 55111-565-40 1 BOTTLE In 1 CARTON contains a BOTTLE 3 40 TABLET In 1 BOTTLE This package is contained within the CARTON (55111-565-40) 4 55111-565-80 1 BOTTLE In 1 CARTON contains a BOTTLE 4 80 TABLET In 1 BOTTLE This package is contained within the CARTON (55111-565-80) 5 55111-565-90 1 BOTTLE In 1 CARTON contains a BOTTLE 5 90 TABLET In 1 BOTTLE This package is contained within the CARTON (55111-565-90) 6 55111-565-18 1 BOTTLE In 1 CARTON contains a BOTTLE 6 180 TABLET In 1 BOTTLE This package is contained within the CARTON (55111-565-18) 7 55111-565-05 1 BOTTLE In 1 CARTON contains a BOTTLE 7 500 TABLET In 1 BOTTLE This package is contained within the CARTON (55111-565-05) 8 55111-565-92 2500 TABLET In 1 POUCH None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090619	01/31/2010

Labeler - Dr. Reddy's Laboratories Limited (862179079)

Revised: 11/2009Dr. Reddy's Laboratories Limited

More Ibuprofen and Diphenhydramine resources

• Ibuprofen and Diphenhydramine Side Effects (in more detail)
• Ibuprofen and Diphenhydramine Use in Pregnancy & Breastfeeding
• Ibuprofen and Diphenhydramine Drug Interactions
• Ibuprofen and Diphenhydramine Support Group
• 0 Reviews for Ibuprofen and Diphenhydramine - Add your own review/rating

Compare Ibuprofen and Diphenhydramine with other medications

• Insomnia
• Pain

J-Tan D HC

Generic Name: brompheniramine, hydrocodone, and pseudoephedrine (brom fen EER a meen, hye droe KOE dohn, soo doe e FED rin)

Brand Names: Anaplex HD, Bromcomp HC, Bromph HD, Bromplex HD, BroveX HC, Drocon-CS, Endacof HC, J-Tan D HC, M-END, SymTan A, Visvex

What is J-Tan D HC (brompheniramine, hydrocodone, and pseudoephedrine)?

Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is in a group of drugs called narcotics and is similar to codeine. Hydrocodone is a cough suppressant that affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine, hydrocodone, and pseudoephedrine is used to treat cough, sneezing, itching, watery eyes, runny nose, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Brompheniramine, hydrocodone, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about J-Tan D HC (brompheniramine, hydrocodone, and pseudoephedrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not take this medication with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before taking J-Tan D HC (brompheniramine, hydrocodone, and pseudoephedrine)?

Do not use this medication if you are allergic to hydrocodone or other narcotic pain relievers such as fentanyl (Actiq, Duragesic), hydromorphone (Dilaudid, Palladone), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (OxyContin), and oxymorphone (Opana). Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking brompheniramine, hydrocodone, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  kidney or liver disease;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. Hydrocodone may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

How should I take J-Tan D HC (brompheniramine, hydrocodone, and pseudoephedrine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cough or cold medicine is usually taken for only a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydrocodone can be fatal. Overdose symptoms may include extreme dizziness or drowsiness, confusion, feeling restless or nervous, cold and clammy skin, warmth or tingly feeling, nausea, vomiting, slow or shallow breathing, slow heart rate, pinpoint pupils, fainting, seizure (convulsions), or coma.

What should I avoid while taking J-Tan D HC (brompheniramine, hydrocodone, and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Do not drink alcohol while you are taking this medication. Alcohol can increase some of the side effects of brompheniramine, hydrocodone, and pseudoephedrine. Do not take this medication with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Life-threatening side effects may result.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Brompheniramine and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains brompheniramine or pseudoephedrine.

J-Tan D HC (brompheniramine, hydrocodone, and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  severe dizziness, fainting, anxiety, restless feeling, nervousness, or tremor;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, vomiting, stomach pain, constipation, mild loss of appetite;

  
  


• 
  

  mild dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  restless or excitability (especially in children);

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect J-Tan D HC (brompheniramine, hydrocodone, and pseudoephedrine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  a diuretic (water pill), or blood pressure medication;

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril); or

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

  
  

This list is not complete and there may be other drugs that can interact with brompheniramine, hydrocodone, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More J-Tan D HC resources

• J-Tan D HC Use in Pregnancy & Breastfeeding
• J-Tan D HC Drug Interactions
• J-Tan D HC Support Group
• 0 Reviews for J-Tan D HC - Add your own review/rating

• Brompheniramine/Hydrocodone/Pseudoephedrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• SymTan A Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare J-Tan D HC with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine, hydrocodone, and pseudoephedrine.

Isoptin SR Controlled-Release Tablets

Pronunciation: ver-AP-a-mil
Generic Name: Verapamil
Brand Name: Examples include Calan SR and Isoptin SR

Isoptin SR Controlled-Release Tablets are used for:

Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Isoptin SR Controlled-Release Tablets are a calcium channel blocker. It works by relaxing (dilating) your blood vessels, which lowers blood pressure.

Do NOT use Isoptin SR Controlled-Release Tablets if:

• you are allergic to any ingredient in Isoptin SR Controlled-Release Tablets


• you have certain heart problems (eg, left ventricular dysfunction, sick sinus syndrome, second- or third-degree heart block and do not have a pacemaker), very low blood pressure, or moderate to severe congestive heart failure (CHF)


• you have atrial fibrillation or flutter and a pre-excitation syndrome (extra conduction pathway in the heart), such as Wolff-Parkinson-White (WPW) syndrome or Lown-Ganong-Levine (LGL) syndrome


• you have shock due to serious heart problems


• you are taking dofetilide, or you have taken disopyramide within the past 48 hours

Contact your doctor or health care provider right away if any of these apply to you.

Before using Isoptin SR Controlled-Release Tablets:

Some medical conditions may interact with Isoptin SR Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart failure or a recent heart attack with lung congestion, low blood pressure, or heart problems (eg, a very slow heart rate, heart block, heart valve disease)


• if you have kidney or liver problems, muscular dystrophy, or a neuromuscular disease


• if you are taking another blood pressure medicine or you are being treated for cancer

Some MEDICINES MAY INTERACT with Isoptin SR Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), clonidine, disopyramide, ketolides (eg, telithromycin), macrolides (eg, erythromycin), or ritonavir because they may increase the risk of Isoptin SR Controlled-Release Tablets's side effects


• Phenobarbital, rifampin, or St. John's wort because they may decrease Isoptin SR Controlled-Release Tablets's effectiveness


• Aldosterone blockers (eg, eplerenone), aspirin, carbamazepine, colchicine, cyclosporine, digoxin, dofetilide , doxorubicin, , dronedarone, eletriptan, erythromycin, everolimus, flecainide, HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), lithium, narcotic pain relievers (eg, fentanyl), paclitaxel, quinazolines (eg, terazosin), quinidine, ranolazine, theophyllines, or tolvaptan because the risk of their side effects may be increased by Isoptin SR Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Isoptin SR Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Isoptin SR Controlled-Release Tablets:

Use Isoptin SR Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Isoptin SR Controlled-Release Tablets by mouth with or without food.


• Check with your doctor before you eat grapefruit or drink grapefruit juice while you use Isoptin SR Controlled-Release Tablets.


• Swallow Isoptin SR Controlled-Release Tablets whole. Do not crush or chew before swallowing.


• Taking Isoptin SR Controlled-Release Tablets at the same time each day will help you remember to take it.


• If you miss a dose of Isoptin SR Controlled-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Isoptin SR Controlled-Release Tablets.

Important safety information:

• Isoptin SR Controlled-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Isoptin SR Controlled-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Isoptin SR Controlled-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Isoptin SR Controlled-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Tell your doctor or dentist that you take Isoptin SR Controlled-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver function, kidney function, complete blood cell counts, and blood pressure, may be performed while you use Isoptin SR Controlled-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Isoptin SR Controlled-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Isoptin SR Controlled-Release Tablets should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Isoptin SR Controlled-Release Tablets while you are pregnant. Isoptin SR Controlled-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Isoptin SR Controlled-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Isoptin SR Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; fatigue; headache; lightheadedness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; lightheadedness, especially when standing; severe dizziness; shortness of breath; swelling of the feet or hands; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, severe or persistent stomach pain, fever, general feeling of being unwell); unusually fast, slow, or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Isoptin SR side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased mental status; dizziness; loss of consciousness; seizures; shortness of breath; slow or irregular heartbeat.

Proper storage of Isoptin SR Controlled-Release Tablets:

Store Isoptin SR Controlled-Release Tablets between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Isoptin SR Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Isoptin SR Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Isoptin SR Controlled-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Isoptin SR Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Isoptin SR resources

• Isoptin SR Side Effects (in more detail)
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