Label: SIMETHICONE tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 19, 2022

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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?

    DISTRIBUTED BY: 

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • package Label

    image description

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0791(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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code 44;137
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0791-150 in 1 BOX04/11/2022
    1NDC:17856-0791-21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/10/2022
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-0791)
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