Label: SIMETHICONE 80 MG- simethicone tablet, chewable

  • NDC Code(s): 69618-033-01
  • Packager: Reliable 1 Laboratories LLC
  • 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 April 30, 2019

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

  • 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

    www.reliable1labs.com

  • Active ingredient (in each chewable tablet)

    Simethicone 80 mg

  • Purpose

    Antiflatulent

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-033-01

    Simethicone 80 mg

    ANTIFLATULENT

    100 CHEWABLE TABLETS

    Simethicone 80mg

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 80 MG 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE (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:69618-033-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2018
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33204/24/2018
    Labeler - Reliable 1 Laboratories LLC (079718111)