Naproxen Sodium and Diphenhydramine

FDA Drug Profile — Naproxen Sodium and Diphenhydramine HCl

Drug Details

Generic Name
Naproxen Sodium and Diphenhydramine
Brand Names
Naproxen Sodium and Diphenhydramine HCl
Application Number
ANDA209726
Sponsor
Amneal Pharmaceuticals NY LLC
NDC Codes
1
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM

Indications and Usage

USE(S) for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

Warnings

WARNINGS Allergy alert: Naproxen sodium 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 use more than directed or for longer than directed.