Drugplain

Aleve 220 mg/1

NAPROXEN SODIUM · TABLET · Navajo Manufacturing Company Inc.

2 Recalls on Record
Plain English

Aleve is a tablet containing naproxen sodium at 220 mg/1, taken oral. Manufactured by Navajo Manufacturing Company Inc..

Key Facts

Brand Name
Aleve
Generic Name
NAPROXEN SODIUM
NDC Code (Product)
67751-144
Manufacturer
Navajo Manufacturing Company Inc.
Strength
220 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
NDA020204
Marketing Start
09/17/2016

Recall History

2 Recalls on Record
Class II12/26/2025

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

OngoingVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective17,878 reports
pain10,456 reports
fatigue10,301 reports
product use issue8,294 reports
rash7,982 reports
off label use7,779 reports
abdominal discomfort7,508 reports
arthralgia7,295 reports
rheumatoid arthritis7,179 reports
headache6,983 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 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period Children under 12 years ask a doctor

Frequently Asked Questions

What is Aleve used for?

Aleve contains NAPROXEN SODIUM. It is a tablet taken oral. Consult your doctor for specific uses.

Is Aleve a controlled substance?

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

What is the generic name for Aleve?

The generic name for Aleve is NAPROXEN SODIUM. There are 12 other brand versions of NAPROXEN SODIUM.

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

The NDC (National Drug Code) for Aleve 220 mg/1 is 67751-144, listed by Navajo Manufacturing Company Inc..

Product NDC

67751-144

Package NDC

67751-144-01

Other Naproxen Brands

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

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