Ibuprofen and Diphenhydramine

Package insert / prescribing information
Generic name: Ibuprofen and Diphenhydramine citrate
Dosage form: tablet
Drug class: Analgesic combinations

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

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 an 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

• 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 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
• 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 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
• 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?

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 by:

Dr. Reddy’s Laboratories Limited

Bachepalli – 502 325 INDIA.

PRINCIPAL DISPLAY PANEL

Container:

Container carton

Medical Disclaimer