Naproxen Sodium Tablet
FDA Label NDC 37835-594

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Naproxen Sodium (NDC 37835-594). 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 active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each caplet)

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

*nonsteroidal anti-inflammatory drug

Purpose

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

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

Ask A Doctor Or Pharmacist Before Use If You Are

• under a doctor's care for any serious condition

• taking aspirin for heart attack or stroke, because naproxen may decrease this benifits of aspirin

• taking any other drug

When Using This Product

• take with food or milk if stomach upset occurs

Stop Use And Ask 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
• you have symptoms of heart problems or stroke: 
    •chest pain
    •trouble breathing 
    •weakness in one part or side of body
    •slurred speech
    •leg swelling
• 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

Pregnancy/Breastfeeding

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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 (1-800-222-1222) 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 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

Other Information

  • each caplet contains:sodium 20 mg
  • store at 20 - 25°C (68 - 77°F).
  • avoid high humidity and excessive heat above 40°C (104°F)
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

Questions?

call toll free 1-844-912-4012

Principal Display Panel-100 Count

NDC 37835-594-01

Compare to the active ingredients in ALEVE ®**

FAST LONG-LASTING PAIN RELIEF

NAPROXEN SODIUM

CAPLETS 220 MG

PAIN RELIEVER/FEVER REDUCER (NSAID)

WITH 8 TO 12 HOUR DOSING

100 Caplets

**This product is not manufactured or distributed by the owner of the registered trademark ALEVE ®.

Label (Label 100)

Label (Label 100)

Principal Display Panel-300 Count

NDC 37835-594-03

Compare to the active ingredients in ALEVE ®**

FAST LONG-LASTING PAIN RELIEF

NAPROXEN SODIUM

CAPLETS 220 MG

PAIN RELIEVER/FEVER REDUCER (NSAID)

WITH 8 TO 12 HOUR DOSING

300 Caplets

**This product is not manufactured or distributed by the owner of the registered trademark ALEVE ®.

Label (Label 300)

Label (Label 300)

* Please review the disclaimer below.