SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [RELIABLE 1 LABORATIRES LLC]

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SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [RELIABLE 1 LABORATIRES LLC]
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NDC 69618-032-06
Set ID 330aed4b-7109-09b8-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Reliable 1 Laboratires LLC
Generic Name
Product Class
Product Number
Application Number PART332
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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)
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