Naproxen Sodium Back and Muscle Pain 220 mg/1

Naproxen Sodium · TABLET, COATED · Dr.Reddy's Laboratories Inc

No Recall History

Plain English

Naproxen Sodium Back and Muscle Pain is a tablet, coated containing naproxen sodium at 220 mg/1, taken oral. Manufactured by Dr.Reddy's Laboratories Inc.

Key Facts

Brand Name: Naproxen Sodium Back and Muscle Pain
Generic Name: Naproxen Sodium
NDC Code (Product): 43598-074
Manufacturer: Dr.Reddy's Laboratories Inc
Strength: 220 mg/1
Dosage Form: TABLET, COATED
Route: ORAL
Marketing Status
Application #: ANDA075168
Marketing Start: 12/10/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective2,873 reports

fatigue2,619 reports

off label use2,508 reports

pain2,446 reports

rash2,238 reports

diarrhoea2,196 reports

arthralgia2,195 reports

vomiting2,127 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 tablet/caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets/caplets within the first hour do not exceed 2 tablets/caplets in any 8 to 12 hour period do not exceed 3 tablets/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 everyday 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 Back and Muscle Pain used for?

Naproxen Sodium Back and Muscle Pain contains Naproxen Sodium. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Naproxen Sodium Back and Muscle Pain a controlled substance?

Naproxen Sodium Back and Muscle Pain is not classified as a controlled substance by the DEA.

What is the generic name for Naproxen Sodium Back and Muscle Pain?

The generic name for Naproxen Sodium Back and Muscle Pain is Naproxen Sodium. There are 12 other brand versions of Naproxen Sodium.

What is the NDC code for Naproxen Sodium Back and Muscle Pain 220 mg/1?

The NDC (National Drug Code) for Naproxen Sodium Back and Muscle Pain 220 mg/1 is 43598-074, listed by Dr.Reddy's Laboratories Inc.

Product NDC

43598-074

Package NDC

43598-074-01

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)