Label: EXTRA STRENGTH GAS RELIEF- simethicone tablet, chewable

  • NDC Code(s): 57896-694-03
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • Active ingredient (in each tablet)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Use

    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 4 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)
    • protect from moisture
  • Inactive ingredients

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

  • Questions or comments?

    1-800-540-3765

  • package label

    1

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-694
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorMINTImprint Code AP040
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-694-0330 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00203/01/2020
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - Geri-Care Pharmaceuticals, Corp (611196254)
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