Bayer Aleve
Bayer Aleve is an FDA drug label for the active ingredient NAPROXEN SODIUM manufactured by Acme United Corporation administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230320.
Generic: NAPROXEN SODIUM
Manufacturer: Acme United Corporation
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 0924-6000
Application: NDA020204
Effective: 20230320
Active Ingredients: Active ingredient (in each caplet) Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Indications & Usage
Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Dosage & Administration
Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults and children: (12 years and older) take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8 to 12- hour period do not exceedc3 caplets in a 24- hour period. Children under 12 years: ask a doctor
Contraindications
Not available.
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: NSAID,s except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. This risk is higher if you use more than directed or for longer than directed.
Adverse Reactions
Not available.
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