DRUG FACTS

ACTIVE INGREDIENT

Active Ingredient(s)                                                                  

(In each capsule)

Diphenhydramine hydrochloride 25 mg

Solubilized Ibuprofen equal to Ibuprofen 200 mg (NSAID)* (Present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

PURPOSE

•   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

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

•   stomach bleeding warning applies to you
•   you have problems or serious side effects from taking pain relievers or fever reducers
•   you have a history of stomach problems, such as heartburn
•   you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
•   you are taking a diuretic
•   you have a breathing problem such as emphysema or chronic bronchitis
•   you have glaucoma
•   you have trouble urinating due to an enlarged prostate gland

ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE

•   taking sedatives or tranquilizers, or any other sleep-aid
•   under a doctor's care for any continuing medical illness
•   taking any other antihistamines
•   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 experience any of the following signs of stomach bleeding:                                                                                              

        •  feel faint

        •  vomit blood  

       •  have bloody or black stools

       •  have stomach pain that does not get better

• 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.

• 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 REACH OF CHILDREN

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

DIRECTIONS

1. do not take more than directed
2. adults and children 12 years and over: take 2 capsules at bedtime
3. do not take more than 2 capsules in 24 hours

OTHER INFORMATION

•   Each capsule contains: potassium 20 mg
•   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)
•   Protect from light

INACTIVE INGREDIENT

Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water.

Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water.

QUESTIONS OR COMMENTS?

Call 1-800-426-9391 

8:30 AM to 4:00 PM ET, Monday-Friday

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