Label: GAS RELIEF- simethicone tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • Active ingredient (in each tablet)

    Simethicone 80 mg

  • Purpose

    Anti-Gas

  • Uses

    for the relief of

    •
    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. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • chew thoroughly
    • 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

    •
    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)
  • Inactive ingredients

    dextrose, sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silica, sorbitol, stearic acid

  • Questions or comments?

    1-800-540-3765

  • package Label

    71205-737-30
  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-737(NDC:57896-799)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code AP019
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-737-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2022
    2NDC:71205-737-6060 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2022
    3NDC:71205-737-9090 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00202/01/2020
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-737) , RELABEL(71205-737)
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