Label: CALCIUM CARBONATE (ANTACID)- calcium carbonate 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 January 11, 2021

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  • Active ingredient (in each tablet)

    Calcium carbonate 10 gr (648 mg, USP)

  • Purpose

    Antacid

  • Uses

    for relief of

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


    Ask a doctor before use if you have

    • kidney stone
    • a calcium-restricted diet

    Ask a doctor or pharmacist before use if

    you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this prouct

    • do not take more than 10 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks

    Keep out of the reach of children.


  • Direction

    • take two to four tablets as symptoms occur or as directed by a doctor
  • Other information

    • each tablet contains: calcium 240 mg
    • store at controlled room temperature 150 to 300C (590 to 860F)
    • use by expiration date on package
  • Inactive ingredients

    croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid

  • Questions? Adverse drug event call:

    (866) 562-2756

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-0377-11

    Manufactured in the U.S.A.

    †Compare to Tums® active ingredient

    Calcium

    Carbonate

    Antacid

    Calcium Rich •Low Sodium Antacid

    THIS PACKAGE FOR HOUSEHOLDS

    WITHOUT YOUNG CHILDREN

    1000 TABLETS

    10 gr (648 mg)

    Calcium Carbonate 648mg Product Label

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE   (ANTACID)
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-377
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code PH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-377-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2006
    2NDC:16103-377-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/29/2006
    Labeler - Pharbest Pharmaceuticals Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals Inc.557054835analysis(16103-377) , manufacture(16103-377) , pack(16103-377) , label(16103-377)
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