Label: GAS RELIEF- simethicone tablet, chewable

  • NDC Code(s): 17714-019-01
  • Packager: Advance Pharmaceutical Inc.
  • 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 December 17, 2018

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

View All Sections
  • Drug Facts

  • Active Ingredient

    (in each chewable tablet)

    Simethicone 80 mg

  • Purpose

    Antiflatulent

  • Uses

    relieves

    • bloating
    • pressure
    • discomfort of gas which can be caused by certain foods or air swallowing
  • Warnings

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

  • Keep out of reach of children

  • Directions

    • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
    • do not exceed 6 tablets per day unless directed by a physician
  • Other Information

    • store at room temperature 15-30 °C (59-86 °F)
    • protect from moisture
  • Inactive Ingredients

    dextrose, dipac sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

  • Questions or Comments

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

  • Package Label

    DC: 17714-019-01  – 100 CHEWABLE TABLETS

    Untitled

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-019
    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)  
    SUCROSE (UNII: C151H8M554)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code AP;019
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-019-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/04/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33211/04/1999
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-019)
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!