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IBUPROFEN by TIME CAP LABORATORIES,INC

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: TIME CAP LABORATORIES,INC
NDC Code: 49483-611

Ibuprofen 200 mg (NSAID)* * nonstreoidal anti-inflammatory drug

Pain reliever / fever reducer

In case of overdose, get medical help or contact a PoisonControlCenter right away. (1-800-222-1222)

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colloidal silicon dioxide, croscamellose sodiium, FD&C yellow #6, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium


do not take more than directed

the smallest effective dose should be used

do not take longer than 10 days, unless directed by a docter
(see Wanings)

adults and children 12 years and olderChildren under 12 years

take 1 tablet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 tablet, 2 tablets may be used

do not exceed 6 tablets in 24 hours, unless directed by a doctor.

ask a doctor

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

Allergy alerts: Ibuprofen may cause a severe allergy 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 NSAID (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

IBUPROFEN TABLETS, USP ORANGE CAPSULE-SHAPED LABEL

IBUPROFEN TABLETS USP 200 MG  ROUND ORANGE 

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-611
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 3350 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code120
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-611-006500 TABLET, FILM COATED in 1 BAG
2NDC:49483-611-0550 TABLET, FILM COATED in 1 BOTTLE
3NDC:49483-611-01100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123711/16/2016
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-612
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 3350 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize15mm
FlavorImprint Code115
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-612-006500 TABLET, FILM COATED in 1 BAG
2NDC:49483-612-0550 TABLET, FILM COATED in 1 BOTTLE
3NDC:49483-612-01100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123711/16/2016
Labeler - TIME CAP LABORATORIES,INC (037052099)
Establishment
NameAddressID/FEIOperations
MARKSANS PHARMA LIMITED925822975manufacture(49483-611, 49483-612)

 
TIME CAP LABORATORIES,INC

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Medically reviewed on Nov 16, 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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