Naproxen Sodium Tablet, Film Coated
FDA Label NDC 58602-738

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Naproxen Sodium (NDC 58602-738). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding naproxen sodium tablets, usp 220 mg, active ingredient (in each tablet), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Naproxen Sodium Tablets, Usp 220 Mg

Drug Facts

Active Ingredient (In Each Tablet)

Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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

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

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 stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

Ask A Doctor Or Pharmacist Before Use If You Are

  • under a doctor's care for any serious condition
  • taking any other drug

When Using This Product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor If

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • you have difficulty swallowing
    • it feels like the pill is stuck in your throat
    • redness or swelling is present in the painful area
    • any new symptoms appear

If Pregnant Or Breast-Feeding,

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center(1-8000-222-1222) right away.

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

Other Information

  • each tablet contains : sodium 20 mg
  • store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive Ingredients

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide

Questions Or Comments?


1-855-274-4122

Do not use if carton is open or if seal over bottle opening is broken or missing.

Manufactured for:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)
509302, India

M.L.No.: 22/MN/AP/2009/F/R

Issued: September 2015

Package Label-Principal Display Panel - 220 Mg (24 Tablets, Container Label)

NDC 58602-738-07
Naproxen Sodium Tablets, USP
220 mg (NSAID)
Pain reliever/fever reducer
STRENGTH TO LAST 12 HOURS
24 Tablets
AUROHEALTH

Package Label-principal Display Panel (220 mg (24 Tablets, Container Label))

Package Label-principal Display Panel (220 mg (24 Tablets, Container Label))


Package Label-Principal Display Panel - 220 Mg (24 Tablets Carton Label)

NDC 58602-738-07
Naproxen Sodium Tablets, USP
220 mg (NSAID)
Pain reliever/fever reducer
STRENGTH TO LAST 12 HOURS
24 Tablets
AUROHEALTH

Package Label-principal Display Panel (220 mg (24 Tablets Carton Label))

Package Label-principal Display Panel (220 mg (24 Tablets Carton Label))

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