Ibuprofen PM Prescribing Information
Package insert / product label
Generic name: diphenhydramine citrate and ibuprofen
Dosage form: tablet, coated
Drug class: Analgesic combinations
Medically reviewed by Drugs.com. Last updated on Feb 15, 2023.
Active ingredient (in each caplet)
Diphenhydramine citrate 38 mg
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Indications and Usage for Ibuprofen PM
- 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
- long term continuous use may increase the risk of heart attack or stroke
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
Ibuprofen PM Dosage and Administration
- 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
Storage and Handling
- 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
colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
MAJOR IBUPROFEN
PM
diphenhydramine citrate and ibuprofen tablet, coated |
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Labeler - Major Pharmaceuticals (191427277) |
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