NAPROXEN SODIUM- naproxen sodium tablet 
Granules USA, Inc.

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Naproxen Sodium Tablets, USP 220 mg (NSAID)**
Pain reliever/fever reducer
STRENGTH TO LAST 12 HOURS

Active ingredient (For Tablet)

(in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)**

**nonsteroidal anti-inflammatory drug

Active ingredient (For Caplet)

(in each caplet)

Naproxen sodium 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

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 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 any other drug

When using this product

■ take with food or milk if stomach upset occurs

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

■ 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

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 the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (For Tablets)

■ 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

Directions (For Caplets)

■ 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 (For Tablet)

■ each tablet contains: sodium 20 mg

■ store at 20 - 25°C (68 - 77°F). Avoid high humidity and excessive heat above 40°C (104°F)

Other information (For Caplet)

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)

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 or comments?

1-877-770-3183 Mon - Fri 9:00 AM to 4:00 PM EST.

Tablets

10 count

Caplets

100ct carton50ct carton10 count

NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69848-010-0110 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
2NDC:69848-010-0550 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
3NDC:69848-010-10100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135307/01/2019
NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69848-009-0110 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135307/01/201912/31/2023
Labeler - Granules USA, Inc. (137098864)

Revised: 1/2024
Document Id: 0dfd5775-138c-c205-e063-6394a90a2022
Set id: 8cb8030c-b281-315c-e053-2a95a90a36f0
Version: 6
Effective Time: 20240102
 
Granules USA, Inc.