Label: IBUPROFEN tablet, film coated

  • NDC Code(s): 49483-611-00, 49483-611-01, 49483-611-05, 49483-612-00, view more
    49483-612-01, 49483-612-05
  • Packager: TIME CAP LABORATORIES,INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 16, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

  • PURPOSE

    Pain reliever / fever reducer

  • KEEP OUT OF REACH OF CHILDREN

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

    Close

  • INACTIVE INGREDIENT

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

  • DOSAGE & ADMINISTRATION


    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

  • INDICATIONS & USAGE

    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

  • WARNINGS

    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

    image description

  • IBUPROFEN TABLETS USP 200 MG  ROUND ORANGE 

    image description

  • INGREDIENTS AND APPEARANCE
    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)