MAGNACAL (CALCIUM CARBONATE) TABLET, CHEWABLE [AFASSCO INC.]

MAGNACAL (CALCIUM CARBONATE) TABLET, CHEWABLE [AFASSCO INC.]
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NDC 51532-0303-2
Set ID 905fcd7a-7d39-448e-8301-3b931ae3ad41
Category HUMAN OTC DRUG LABEL
Packager Afassco Inc.
Generic Name
Product Class
Product Number
Application Number PART331
  • 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

    res

  • 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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