Label: POLARIS MINT ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 69103-2552-5, 69103-2552-6
  • Packager: Provision Medical Products
  • 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 January 5, 2023

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  • INDICATIONS & USAGE

    UseS

    For the relief of-Sour Stomach, Upset Stomach, Heartburn, Acid Indigestion

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health

    professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In

    case of overdose, get medical help or

    contact a Poison Control Center right

    away.

    Prompt medical attention is critical for adults as

    well as for children, even if you do not notice any signs

    or symptoms.

  • WARNINGS

    Warnings:

    Ask a doctor or health professional before use if you are:

    currently taking a prescription drug. Antacids may react

    with certain prescription drugs.

  • DOSAGE & ADMINISTRATION

    Directions:Do not use more thsn directed.  Adults and children 12 years or older.

    Take 2 tablets every 4 to 6 hours or as needed,

    do not exceed 18 tablets in 24 hours, or as

    directed by a doctor. 

    Children under 12 years-Do not give to children under 12 years unless directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    corn startch, D&C Yellow #10,

    FD&C Blue #1, flavor,

    magnesium stearate,

    silicon dioxide, startch,

    sucrose

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT-calcium carbonate 420 MG

  • PURPOSE

    ANTACID

  • PRINCIPAL DISPLAY PANEL

    MINT ANTACID BOX

  • INGREDIENTS AND APPEARANCE
    POLARIS MINT ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2552
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (WHITE WITH GREEN FLECKS) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR14
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-2552-5250 in 1 CARTON04/03/201505/01/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69103-2552-6100 in 1 CARTON04/03/201505/01/2024
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/31/201505/01/2024
    Labeler - Provision Medical Products (036936831)
    Registrant - Provision Medical Products (036936831)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(69103-2552)
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