Ibuprofen and Diphenhydramine citrate

FDA Drug Profile — Advil PM, Advil PM, CVP HEALTH, Advil PM, TRAVEL BASIX

Drug Details

Generic Name
Ibuprofen and Diphenhydramine citrate
Brand Names
Advil PM, Advil PM, CVP HEALTH, Advil PM, TRAVEL BASIX
Application Number
NDA021394
Sponsor
Lil' Drug Store Products, Inc.
NDC Codes
4
Dosage Forms
TABLET, COATED
Routes
ORAL
Active Ingredients
DIPHENHYDRAMINE CITRATE, IBUPROFEN

Indications and Usage

Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

Warnings

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 severe 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 prescription or nonprescription NSAIDs [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 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.