Label: GAS RELIEF- simethicone tablet, chewable

  • NDC Code(s): 57896-799-01, 57896-799-08
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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

View All Sections
  • 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

    1

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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 (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:57896-799-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2020
    2NDC:57896-799-088 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00202/01/2020
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - Geri-Care Pharmaceuticals, Corp (611196254)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!