Label: MAGNACAL- calcium carbonate tablet, chewable

  • 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 21, 2019

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT IN EACH TABLET- CALCIUM CARBONATE 420 MG

  • PURPOSE

    ANTACID

  • INDICATIONS & USAGE

    Uses: For the relief of the following symptoms associated with:

    • acid indigestion • sour stomach

    • heartburn • upset stomach

  • WARNINGS

    Warnings:

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

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

    • do not use a maximum dosage for more than 2 weeks except under the advice of a physician.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children: (12 years and older) 2 or more tablets chewed not to exceed18 tablets in a 24 hour period

    Children: (under 12 years) Do not give to children under 12 years of age unless directed by a doctor.

  • INACTIVE INGREDIENT

    SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

  • OTHER SAFETY INFORMATION

    Other Information:

    Each tablet contains: 168 mg of elemental calcium.

  • PRINCIPAL DISPLAY PANEL

    AfasscoMagnacal12-16

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  • INGREDIENTS AND APPEARANCE
    MAGNACAL 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-0303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MINT (UNII: FV98Z8GITP)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code FR8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51532-0303-22 in 1 PACKET; Type 0: Not a Combination Product10/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/07/2015
    Labeler - Afassco Inc. (609982723)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(51532-0303)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRATAB LABORATORIES, INC.151051757manufacture(51532-0303)
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