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Calcium Carbonate (Roxane Laboratories, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 10 BLISTER PACK in 1 CARTON (0054-8120-25) > 10 TABLET in 1 BLISTER PACK Label Information

Complete Calcium Carbonate Information

  • CALCIUM CARBONATE Tablets (not USP)

    Calcium Supplement


  • Supplement Facts

    Serving Size: 1 Tablet

    Amount Per Serving

    % Daily Value

    Calcium 500 mg

    50 %


  • Active Ingredient

    Each tablet contains 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium).


  • Purpose

    Antacid


  • Keep Out of Reach of Children

    Keep bottle tightly closed. Store in a cool, dry place, out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.


  • Uses

    For the prevention of calcium deficiency in adults.


  • Warnings

    Do not use more than directed.

    As with any supplement, if you are pregnant or nursing a baby, contact your healthcare professional before use.

    Do not use if printed foil under cap is broken or missing.


  • Directions

    Take one tablet two to three times daily with meals, or as directed by a physician.


  • Storage and Handling

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]


  • Inactive Ingredients

    Magnesium stearate and microcrystalline cellulose.


  • Questions or Comments

    Call 1-800-962-8364. You may also report serious side effects to this phone number.

    Distr by: West-Ward

    Pharmaceuticals Corp.

    Eatontown, NJ 07724

    Revised March 2016


  • Package/Label Principal Display Panel

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  • Package/Label Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 
    calcium carbonate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0054-4120
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 1250 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape CAPSULE Size 19mm
    Flavor Imprint Code 54;302
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0054-4120-25 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/18/2004 05/24/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 11/18/2004 05/24/2019
    CALCIUM CARBONATE 
    calcium carbonate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0054-8120
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 1250 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape CAPSULE Size 19mm
    Flavor Imprint Code 54;302
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0054-8120-25 10 in 1 CARTON 11/18/2004 05/24/2019
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 11/18/2004 05/24/2019
    Labeler - West-Ward Pharmaceuticals Corp. (080189610)
    Establishment
    Name Address ID/FEI Business Operations
    West-Ward Columbus Inc. 058839929 MANUFACTURE(0054-4120, 0054-8120)