Label: SIMETHICONE - dimethicone tablet, chewable 

  • NDC Code(s): 57896-791-01
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/13

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

  • Active ingredient (in each tablet)

    Simethicone 80 mg

    Close
  • Purpose

    Anti-Gas

    Close
  • Uses

    For the relief of pressure and bloating commonly referred to as gas

    Close
  • Warnings

    When using this product • do not take more than directed, except under the advice of a doctor

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

    Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

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

    Close
  • Directions

    • adults and children over 12 years, chew 1-2 tablets as needed after meals and at bedtime

      • chew thoroughly

      • do not exceed 6 tablets in 24 hours

    • children under 12 years, consult a doctor

    Close
  • Other information

    • store at room temperature, 15°C - 30°C (59˚F - 86˚F)
    • package not child resistant
    Close
  • Inactive ingredients

    dextrose, peppermint flavor, silica, sorbitol, stearic acid, talc, calcium phosphate.

    Close
  • package Label

    GERICARE

    NDC 57896-791-01

    CHEWABLE

    SIMETHICONE

    TABLETS USP, 80mg

    FOR GAS DISTRESS

    MINT FLAVOR

    100 Tablets

    80 mg each

    Chewable Simethicone label

    Close
  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57896-791
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    DEXTROSE  
    SILICON DIOXIDE  
    SORBITOL  
    STEARIC ACID  
    TALC  
    TRICALCIUM PHOSPHATE  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 13mm
    Flavor PEPPERMINT Imprint Code 44;137
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57896-791-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 01/01/2004
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - Geri-Care Pharmaceuticals, Corp (611196254)
    Close