Label: SIMETHICONE tablet, chewable

  • NDC Code(s): 57896-791-01, 57896-791-08
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 26, 2023

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  • Active ingredient (in each tablet)

    Simethicone 80 mg

  • Purpose

    Anti-Gas

  • Uses

    relieves pressure, bloating, and fullness
    commonly referred to as gas

  • Warnings

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • chew or crush tablet completely before swallowing
    • adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime.

    Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.

    • children under 12 years: ask a doctor
  • Other information

    • each tablet contains: calcium 65 mg
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
    • store at room temperature, 15°C - 30°C (59˚F - 86˚F)
    • protect from moisture
  • Inactive ingredients

    cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
    magnesium stearate, silica, sucralose, calcium phosphate.

  • Questions or comments?

    1-800-540-3765

  • package Label

    12

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-791
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    DEXTRATES (UNII: G263MI44RU)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code 44;137
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-791-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2016
    2NDC:57896-791-0880 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00201/01/2004
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - Geri-Care Pharmaceuticals, Corp (611196254)
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