Label: SIMETHICONE 80 MG- simethicone tablet, chewable

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

Drug Label Information

Updated November 1, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Use

    relieves bloating, pressure and fullness commonly referred to as gas

  • Warnings

    Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    •
    thoroughly chew 1-2 tablets as needed after meals and at bedtime
    •
    do not take more then 6 tablets per day
  • Other information

    store at room temperature 15°-30°C (59°-86°F)

  • Inactive ingredients

    compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid

  • Questions or comments?

    call 516-341-0666, 8:30 am to 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reliable 1 Laboratories LLC

    Valley Stream, NY 11580

    Repackaged by: Proficient Rx LP

    Thousand Oaks, CA 91320

    www.reliable1labs.com

  • Active ingredient (in each chewable tablet)

    Simethicone 80 mg

  • Purpose

    Antiflatulent

  • PRINCIPAL DISPLAY PANEL

    NDC 82804-043-30

    Simethicone 80 mg

    ANTIFLATULENT

    30 CHEWABLE TABLETS

    82804-043-30
  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 80 MG 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82804-043(NDC:69618-033)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Product Characteristics
    Colorwhite (Off White) Scoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code AP;019
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82804-043-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2023
    2NDC:82804-043-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2023
    3NDC:82804-043-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2023
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00204/24/2018
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(82804-043) , RELABEL(82804-043)
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!