EXTRA STRENGTH GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]

EXTRA STRENGTH GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]
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NDC 57896-691-03
Set ID 612d55f3-54b0-488c-e053-2991aa0ae025
Category HUMAN OTC DRUG LABEL
Packager Geri-Care Pharmaceuticals, Corp
Generic Name
Product Class
Product Number
Application Number PART332
  • Active ingredient (in each tablet)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Use

    for the relief of pressure, bloating, and fullness commonly referred to as gas

  • Warnings

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults: chew 1 or 2 tablets as needed after meals and at bedtime
    • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
  • Other information

    • each tablet contains: calcium 89 mg
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
    • store at controlled room temperature
    • protect from moisture
  • Inactive ingredients

    cherry flavor, D&C red #27 lake, D&C red #30 lake, dextrates, FD&C red #40 lake, silica gel, sorbitol, starch, stearic acid, talc, tri-calcium phosphate

  • package label

    gc

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-691
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DEXTRATES (UNII: G263MI44RU)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize14mm
    FlavorCHERRYImprint Code 44;608
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-691-0330 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33211/01/2015
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - Geri-Care Pharmaceuticals, Corp (611196254)