Label: SIMETHICONE 125 MG- simethicone tablet, chewable

  • NDC Code(s): 69618-032-06
  • Packager: Reliable 1 Laboratires 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 March 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewable tablet)

    Simethicone 125 mg

  • PURPOSE

    Antiflatulent

  • 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 than 4 tablets per day
  • Other information

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

  • Inactive ingredients

    compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

  • Questions or comments?

    call 516-341-0666, 8:30 am -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

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Mylanta®

    Distributed by: Reliable 1 Laboratories LLC

    Valley Stream, NY 11580

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-032-06

    Simethicone 125 mg

    ANTIFLATULENT

    60 CHEWABLE TABLETS

    *Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH

    Simethicone 125mg

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 125 MG 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-032
    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)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (Off white) Score2 pieces
    ShapeROUNDSize16mm
    FlavorImprint Code AP;040
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-032-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33204/25/2018
    Labeler - Reliable 1 Laboratires LLC (079718111)
    Registrant - Simethicone 125 mg (079718111)
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