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

  • 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 July 11, 2019

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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 Supplied section 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 finalpart33102/28/2019
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-301)
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