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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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Further information

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

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