Label: APCAL - calcium carbonate and cholecalciferol tablet 

  • NDC Code(s): 46084-071-12, 46084-071-13, 46084-071-14, 46084-071-15, view more
    46084-071-16
  • Packager: A P J Laboratories limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • WARNINGS

    Ask a doctor or pharmacist before use if you are taking a prescription drug.

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  • INACTIVE INGREDIENT

    STARCH, CORN Close
  • INACTIVE INGREDIENT

    GELATIN Close
  • INACTIVE INGREDIENT

    METHYLPARABEN Close
  • INACTIVE INGREDIENT

    TITANIUM DIOXIDE Close
  • INACTIVE INGREDIENT

    TALC Close
  • INACTIVE INGREDIENT

    SODIUM STARCH GLYCOLATE TYPE A POTATO Close
  • INACTIVE INGREDIENT

    SILICON DIOXIDE Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Close
  • PURPOSE

    Supplement Close
  • INDICATIONS & USAGE

    Enter section text here

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  • PRINCIPAL DISPLAY PANEL

    product
    product picture
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  • ACTIVE INGREDIENT

    Enter section text here

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  • DOSAGE & ADMINISTRATION

     Calcium Carbonate 1250 mg Vitamin D3 250 IU Close
  • INGREDIENTS AND APPEARANCE
    APCAL 
    calcium carbonate and vitamin d3 tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46084-071
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE 1250 mg
    CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 250 [iU]
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN 20 mg
    GELATIN 2 mg
    METHYLPARABEN 2 mg
    TITANIUM DIOXIDE .1 mg
    MAGNESIUM STEARATE 20 mg
    TALC 20 mg
    SODIUM STARCH GLYCOLATE TYPE A POTATO 10 mg
    SILICON DIOXIDE 10 
    Product Characteristics
    Color white (White) Score score with uneven pieces
    Shape CAPSULE (scoreline) Size 20mm
    Flavor Imprint Code 1335mg
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46084-071-16 500 in 1 BLISTER PACK
    2 NDC:46084-071-15 250 in 1 BLISTER PACK
    3 NDC:46084-071-14 120 in 1 BLISTER PACK
    4 NDC:46084-071-13 60 in 1 BLISTER PACK
    5 NDC:46084-071-12 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 03/01/2013
    Labeler - A P J Laboratories limited (677378339)
    Registrant - A P J Laboratories limited (677378339)
    Establishment
    Name Address ID/FEI Business Operations
    A P J Laboratories limited 677378339 manufacture(46084-071)
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