IBUPROFEN- ibuprofen tablet, film coated 
TIME CAP LABORATORIES,INC

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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

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IBUPROFEN TABLETS USP 200 MG  ROUND ORANGE 

image description

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-611
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code 120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-611-006500 in 1 BAG; Type 0: Not a Combination Product11/16/2016
2NDC:49483-611-0550 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
3NDC:49483-611-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize15mm
FlavorImprint Code 115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-612-006500 in 1 BAG; Type 0: Not a Combination Product11/16/2016
2NDC:49483-612-0550 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
3NDC:49483-612-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123711/16/2016
Labeler - TIME CAP LABORATORIES,INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-611, 49483-612)

Revised: 11/2016
Document Id: 3aacf896-adf0-47fb-9cc4-a85ee9f61367
Set id: 82aad715-f652-471b-840c-5151c66e5ade
Version: 1
Effective Time: 20161116
 
TIME CAP LABORATORIES,INC