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NAPROXEN SODIUM by TIME CAP LABORATORIES, INC

Dosage form: tablet, film coated
Ingredients: NAPROXEN SODIUM 220mg
Labeler: TIME CAP LABORATORIES, INC
NDC Code: 49483-609

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

Colloidal Silicon Dioxide

Croscarmellose Sodium

FD&C Blue #2 Lake

Hypromellose

Magnesium Cellulose

Polyethylene Glycol

Povidone

Titanium Dioxide

do not take more than directed
the smallest effective dose should be used
drink a full glass of water with each dose

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
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 older
have bad stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take 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:49483-609
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
ShapeROUNDSize10mm
FlavorImprint Code141
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-609-006500 TABLET, FILM COATED in 1 BAG
2NDC:49483-609-0550 TABLET, FILM COATED in 1 BOTTLE
3NDC:49483-609-01100 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(49483-609)

 
TIME CAP LABORATORIES, INC

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Medically reviewed on Mar 28, 2018

Further information

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

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