Drugplain

Naproxen Sodium 550 mg/1

Naproxen Sodium · TABLET · ST. MARY'S MEDICAL PARK PHARMACY

5 Recalls on Record
Plain English

Naproxen Sodium is a tablet containing naproxen sodium at 550 mg/1, taken oral. Manufactured by ST. MARY'S MEDICAL PARK PHARMACY.

Key Facts

Brand Name
Naproxen Sodium
Generic Name
Naproxen Sodium
NDC Code (Product)
60760-801
Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY
Strength
550 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA212199
Marketing Start
05/09/2024

Recall History

5 Recalls on Record
Class II03/13/2025

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II08/27/2021

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II08/27/2021

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II10/10/2014

Contract Packaging Resources Inc.

Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective2,884 reports
fatigue2,621 reports
off label use2,511 reports
pain2,461 reports
rash2,240 reports
arthralgia2,199 reports
diarrhoea2,199 reports
vomiting2,128 reports
condition aggravated2,101 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 exceed 3 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 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 you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you you have a history of s…

Frequently Asked Questions

What is Naproxen Sodium used for?

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

Is Naproxen Sodium a controlled substance?

Naproxen Sodium is not classified as a controlled substance by the DEA.

What is the generic name for Naproxen Sodium?

The generic name for Naproxen Sodium is Naproxen Sodium. There are 8 other brand versions of Naproxen Sodium.

What is the NDC code for Naproxen Sodium 550 mg/1?

The NDC (National Drug Code) for Naproxen Sodium 550 mg/1 is 60760-801, listed by ST. MARY'S MEDICAL PARK PHARMACY.

Product NDC

60760-801

Package NDC

60760-801-14

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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