Label: CAREONE EXTRA STRENGTH GAS RELIEF- simethicone tablet, chewable

  • NDC Code(s): 72476-019-73
  • Packager: Retail Business Services, 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 September 28, 2018

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  • ACTIVE INGREDIENT(in each tablet)

    Simethicone 125 mg

  • PURPOSE

    Anti-gas

  • USE(S)

    relieves:

    • pressure
    • bloating
    • symptoms referred to as gas
  • WARNINGS

    .

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a poison control center immediately.

  • DIRECTIONS

    • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
    • do not exceed 4 tablets in a 24 hour period except under the advice and supervision of  a physician
  • OTHER INFORMATION

    • do not use if any individual blister unit is broken or open
    • store at room temperature
    • avoid high humidity and excessive heat, above 40ºC (104ºF)
  • INACTIVE INGREDIENTS

    D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

  • PRINCIPAL DISPLAY PANEL

    NDC 72476-019-73

    Careone

    Compare to the Active Ingredient in Gas-X® Chewables Extra Strength*
    EXTRA STRENGTH
    GAS RELIEF
    Simethicone 125 mg - Anti-Gas

    Cherry Creme
    FAST RELIEF OF:

    • DISCOMFORT FROM GAS
    • BLOATING
    • PRESSURE

     

    18 chewable tablets
    102

  • INGREDIENTS AND APPEARANCE
    CAREONE EXTRA STRENGTH GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-019
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize14mm
    FlavorCHERRYImprint Code G134
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-019-733 in 1 CARTON10/13/2021
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33210/13/2021
    Labeler - Retail Business Services, LLC. (967989935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(72476-019)
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