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Naproxen Sodium by FREDS INC

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: FREDS INC
NDC Code: 55315-992

ALL DAY PAIN RELIEF
Naproxen Sodium Tablets, USP 220 mg

Active ingredient
(in each tablet)

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

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 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

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

■ each tablets contains: sodium 20 mg

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

Inactive ingredients

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

Questions or comments?

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

ALL DAY PAIN RELIEF
Naproxen Sodium Tablets, USP 220 mg
Pain Reliever/Fever Reducer (NSAID)
GLUTEN-FREE
STRENGTH TO LAST 12 HOURS
24 Tablets

ALL DAY PAIN RELIEF
Naproxen Sodium Tablets, USP 220 mg
GLUTEN-FREE
Pain Reliever/Fever Reducer (NSAID)
STRENGTH TO LAST 12 HOURS

24 Caplets+
+ Capsule-Shaped Tablets

ALL DAY PAIN RELIEF
Naproxen Sodium Tablets, USP 220 mg
GLUTEN-FREE
Pain Reliever/Fever Reducer (NSAID)
STRENGTH TO LAST 12 HOURS
50 Caplets+
+ Capsule-Shaped Tablets

ALL DAY PAIN RELIEF
Naproxen Sodium Tablets, USP 220 mg
GLUTEN-FREE
Pain Reliever/Fever Reducer (NSAID)
STRENGTH TO LAST 12 HOURS
100 Caplets+
+ Capsule-Shaped Tablets

NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-992
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOLS 
FD&C BLUE NO. 2 
HYPROMELLOSES 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TITANIUM DIOXIDE 
STARCH, CORN 
MICROCRYSTALLINE CELLULOSE 
STEARIC ACID 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code220
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-992-2424 TABLET in 1 BOTTLE
2NDC:55315-992-0550 TABLET in 1 BOTTLE
3NDC:55315-992-10100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135308/17/2017
NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-991
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TITANIUM DIOXIDE 
MICROCRYSTALLINE CELLULOSE 
STEARIC ACID 
FD&C BLUE NO. 2 
HYPROMELLOSES 
STARCH, CORN 
POLYETHYLENE GLYCOLS 
POVIDONE K30 
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize9mm
FlavorImprint CodeI1
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-991-2424 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135308/17/2017
Labeler - FREDS INC (005866116)

 
FREDS INC

← See all Naproxen Sodium brands

Medically reviewed on Jul 19, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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