Naproxen Sodium by Bi-Mart / Granules India Ltd NAPROXEN SODIUM tablet

Naproxen Sodium by

Drug Labeling and Warnings

Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, Granules India Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

Distributed by:

BI-MART

Eugene, OR 97402

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 ®.

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 ®.

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-594
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	OVAL (Caplet -Shaped)	Size	12mm
Flavor		Imprint Code	220
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-594-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2025
2	NDC: 37835-594-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091353	09/30/2011

Labeler - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Ltd		918609236	manufacture(37835-594)