Label: BIO V ANTACID FRUIT FLAVORS- calcium carbonate tablet

  • 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 December 22, 2021

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  • Drug Facts

  • Active ingredient (per tablet)

    Calcium Carbonate 500mg

    Purpose

    Antacid

  • USE

    relieves

    • heartburn • acid indigestion • sour stomach • upset stomach associated with these symptoms

  • Warnings

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    • do not take more than 15 tablets in 24 hours
    • if pregnant do not take more than 10 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks except under the adive and supervision of a doctor

    Keep out of reach of children

  • Directions

    • adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor 
    • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other information

    • each tablet contains: elemental calcium 200mg
    • store at room temperature. Keep the container tightly closed.
  • Inactive ingredients

    D&C Red No.27, D&C Yellow No. 10, dextrose, FD&C Blue No.2, FD&C Yellow No.6, flavors, guar gum, hypromellose, magnesium stearate, sucralose.

  • Questions or comments?

    1-844-699-2468   

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    BIO V ANTACID FRUIT FLAVORS 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71481-000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION500 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    GUAR GUM (UNII: E89I1637KE)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Coloryellow (Orange/Green/Pink) Score2 pieces
    ShapeROUNDSize15mm
    FlavorImprint Code NO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71481-000-01150 in 1 BOTTLE; Type 0: Not a Combination Product12/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/22/2021
    Labeler - BioV Health Inc (204308337)
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