GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]

GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-2860-0
Set ID 69840f03-0fbb-49b4-a85f-e85f3f22cf20
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class
Product Number
Application Number PART332
  • Active ingredients

     Simethicone 80 mg

  • Purpose

     Antigas

  • Use(s)

     relieves these symptoms associated with gas

    • bloating
    • pressure
    • stuffed feeling
    • fullness
  • Warnings

    If pregnant or breast-feeding,

     ask a health professional before use.

    Keep out of reach of children.

  • Directions

    •  do not exceed 6 tablets per day unless directed by a doctor
    • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
  • Other information

    • store at room temperature
    • avoid high humidity and excessive heat, above 40ºC (104ºF) 
  • Inactive ingredients

     dextrose, peppermint flavor, silica gel, sorbitol, stearic acid, talc, tri-calcium phosphate

  • Principal display panel

    NDC 54868-2860-0

    Product Packaging

    Simethicone 80 mg

    Gas Relief

    •Pressure   •Bloating   •Discomfort

    Fast Acting

    Anti Gas

    Mind Flavored

    100 Tablets

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

    50844  REV1104E13712

    DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017



    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma       74146

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2860(NDC:37205-112)
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code 44;137
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2860-0100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33205/17/1995
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel