Label: THERAFLEX ADVANCE (ibuprofen, glucosamine sulfate, and chondroitin sulfate- bovine tablet

  • NDC Code(s): 61841-152-12, 61841-152-72
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 13, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each capsule)Purposes
    Glucosamine Sulfate 250 mgDietary Supplement
    Chondroitin Sulfate 200 mgDietary Supplement
    Ibuprofen 100 mgAnalgesic
  • Uses

    • temporarily relieves minor aches and pains associated with
      • backache
      • arthritis.
  • Warnings

    Allergy alert

    Ibuprofen may cause a severe allergic reaction wich may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock.

    Alcohol warning

    If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take ibuprofen or other pain relieves/fever reducers. Ibuprofen may cause stomach bleeding.

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer.

    When using this product

    • take with food or milk if stomach upset occurs.

    I f pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or c omplications during delivery.

  • Directions

    Adults

    Take 1 capsule every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 capsule, 2 capsules may be used, but do not exceed 6 capsules in 24 hours, unless directed by a doctor. The smallest effective dose should be used.

    Children

    Do not give this product to children under 12 unless directed by a doctor.

    Do not exceed recommended dose.

  • Other information

    • store at room temperature, USP.
  • Inactive ingredients

    Corn Starch, Crospovidone, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinylpyrrolidone, Pregelatinized Starch, Silica, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide, FD&C Blue#1 Lake.

  • PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Carton

    THERAFLEX

    ADVANCE

    60 CAPSULES

    Ibuprofen 100 mg

    Glucosamine Sulfate 250 mg

    Chondroitin Sulfate 200 mg

    Carton 60 count

  • INGREDIENTS AND APPEARANCE
    THERAFLEX ADVANCE 
    ibuprofen, glucosamine sulfate, and chondroitin sulfate (bovine) tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61841-152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) (GLUCOSAMINE - UNII:N08U5BOQ1K) GLUCOSAMINE SULFATE250 mg
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) (CONDOLIASE - UNII:7SI2UZG934) CHONDROITIN SULFATE (BOVINE)200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (Blue opaque) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code Theraflex;Advance
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61841-152-721 in 1 CARTON12/11/2014
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:61841-152-121 in 1 CARTON12/11/2014
    2120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/11/2014
    Labeler - Bayer HealthCare LLC. (785159372)