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:
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| 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) |
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