Bayer Aleve 220 mg/1

Naproxen Sodium · TABLET · Acme United Corporation

No Recall History

Plain English

Bayer Aleve is a tablet containing naproxen sodium at 220 mg/1, taken oral. Manufactured by Acme United Corporation.

Key Facts

Brand Name: Bayer Aleve
Generic Name: Naproxen Sodium
NDC Code (Product): 0924-6000
Manufacturer: Acme United Corporation
Strength: 220 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA020204
Marketing Start: 03/24/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,874 reports

fatigue2,620 reports

off label use2,508 reports

pain2,446 reports

rash2,238 reports

arthralgia2,196 reports

diarrhoea2,195 reports

vomiting2,126 reports

condition aggravated2,100 reports

joint swelling2,057 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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

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 stomach ulcers or bleeding problems take a blood thinner (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. The risk is higher if you use more than directed or for longer than directed.

Frequently Asked Questions

What is Bayer Aleve used for?

Bayer Aleve contains Naproxen Sodium. It is a tablet taken oral. Consult your doctor for specific uses.

Is Bayer Aleve a controlled substance?

Bayer Aleve is not classified as a controlled substance by the DEA.

What is the generic name for Bayer Aleve?

The generic name for Bayer Aleve is Naproxen Sodium. There are 12 other brand versions of Naproxen Sodium.

What is the NDC code for Bayer Aleve 220 mg/1?

The NDC (National Drug Code) for Bayer Aleve 220 mg/1 is 0924-6000, listed by Acme United Corporation.

Product NDC

0924-6000

Package NDC

0924-6000-00

Other Naproxen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)