Diphenhydramine Citrate and Ibuprofen Tablets USP 38 mg/200 mg

Drug Facts

Active ingredients (in each caplet)Diphenhydramine citrate USP 38 mg Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purposes

Nighttime sleep-aidPain 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:

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

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, asthma, or had a stroke
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 a doctor or 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

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get better
you have symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swelling
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 at 20 weeks or later in 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

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

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue # 2, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, palmitic acid, polydextrose, polyethylene glycol, pregelatinized starch (maize), sodium lauryl sulfate, sodium starch glycolate, stearic acid, and titanium dioxide. Questions or comments? Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)Distributed by:AUROHEALTH LLC279 Princeton-Hightstown Road, East Windsor NJ 08520 Made in India Code No.: TS/DRUGS/16/2014

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