Label: CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (calcium carbonate 10gr- 648 mg tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2025

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  • Active ingredient (in each tablet)

    Calcium Carbonate 10 gr (648 mg)

  • Purpose

    Antacid

  • Uses

    relieves

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • Warnings


    Ask a doctor before use if you have

    • kidney stones
    • a calcium-restricted diet

    Ask a doctor or pharmacist before use if you are

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

    Stop use and ask a doctor if

    symptoms last more than 2 weeks.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.


  • Directions

    • take one to four tablets daily
    • do not take more than 4 tablets in 24 hours
    • do not use the maximum dosage for more than two weeks
  • Other information

    • each tablet contains: calcium 260 mg
    • store at room temperature
  • Inactive ingredients

    acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

  • Repackaging Information

    Please reference the How Suppliedsection listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count648 mg
    18071610-301-80

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20190711JH

  • PRINCIPAL DISPLAY PANEL - 648 mg

    NDC 71610-301 - Calcium Carbonate 648 mg Tablets
    Bottle Label 648 mg

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 10 GR (648 MG)  (ANTACID)
    calcium carbonate 10gr (648 mg) tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-301(NDC:0536-1206)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE648 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code PH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71610-301-6090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2019
    2NDC:71610-301-65100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/16/2019
    3NDC:71610-301-80180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2019
    4NDC:71610-301-92270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00102/28/2019
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585repack(71610-301)
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