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NAPROXEN SODIUM by TIME CAP LABORATORIES, INC

Medically reviewed on March 28, 2018

Dosage form: tablet, film coated
Ingredients: NAPROXEN SODIUM 220mg
Labeler: TIME CAP LABORATORIES, INC
NDC Code: 49483-608

Naproxen Sodium Tablets, USP
220 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Colloidal Silicon, Croscarmellose sodium, fd&c blue#2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

do not 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 to12 hours while symptoms last

for first dose you may take 2 tablets with in the first hours

do not exceed 2 tablets in any 8 to 12 hour perioddo not exceed 3 tablets in a 24 hours period

children under 12 years: ask a doctor

temporarily relieves minor aches and pain due to: backache headache menstrual cramps minor pain of arthritis muscular aches the common cold ...

temporarily relieves minor aches and pain due to:

backache

headache

menstrual cramps

minor pain of arthritis

muscular aches

the common cold

toothache

temporarily reduces fever

Pain reliever/ fever reducer

Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) blisters ...

Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
asthma (wheezing)blisters;facial swelling;hives;rash;shock;skin reddening

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 olderhave bad stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drug 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.

In case of overdose, get medical help or contact a poison control center right away.

NAPROXEN SODIUM 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-608
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN220 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code144
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-608-006500 TABLET, FILM COATED in 1 BAG
2NDC:49483-608-0550 TABLET, FILM COATED in 1 BOTTLE
3NDC:49483-608-01100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054503/28/2016
Labeler - TIME CAP LABORATORIES, INC (037052099)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIOperations
MARKSANS PHARMA LIMITED925822975manufacture(49483-608)

 
TIME CAP LABORATORIES, INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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