Naproxen Sodium and Diphenhydramine
Naproxen Sodium and Diphenhydramine is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Naproxen Sodium and Diphenhydramine HCl. Available dosage form: tablet, film coated.
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
- NAPROXEN SODIUM, DIPHENHYDRAMINE HYDROCHLORIDE
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.