Acetaminophen PM

FDA Drug Profile — Pain Relief PM

Acetaminophen PM is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Pain Relief PM. Available dosage form: tablet.

Drug Details

Generic Name
Acetaminophen PM
Brand Names
Pain Relief PM
Application Number
part343
Sponsor
Velocity Pharma
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on skin in children under 12 years of age Ask a doctor before use if the you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedative or tranquilizers when using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks, insomnia may be a symptom of serious underlying medical illness. Any new symptoms appear redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days If pregnant or breast-feeding, ask a health professional before use.