Label: CERTI-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 April 12, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients(each tablet)

    Calcium Carbonate 420 mg

  • Purpose

    Antacid

  • Uses

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

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    • do not take more than 19 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks except under advice and supervision of a doctor.
    • If symptoms persist for more than two weeks, stop using this product and see a doctor.

    Keep out of the reach of children.

  • Directions

    • Chew 2 tablets every 2-3 hours or as symptoms occur, repeat hourly if needed.
  • Other information

    • Calcium content per tablet: 168 mg
    • store at room temperature 15 - 30° C (59 - 86° F) in a dry place
    • do not use if package is open or torn
    • read all product information before using.
    • Phenylketonurics: each tablet contains 1.5 mg phenylalanine.
  • Inactive Ingredients

    • aspartame, croscarmellose sodium, magnesium stearate, mint flavor, sorbital.
  • Questions?

    Call 1-800-854-7474

  • PRINCIPAL DISPLAY PANEL - 420 mg Tablet Pouch Box

    Tamper evident
    packaging:
    Do not use if
    open or torn.

    This package for
    households
    without children

    See New Warnings
    Information

    Compare to TUMS®

    CERTI-ANTACID™

    420 mg Calcium Carbonate

    •Antacid

    PRINCIPAL DISPLAY PANEL - 420 mg Tablet Pouch Box
  • INGREDIENTS AND APPEARANCE
    CERTI-ANTACID 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48083-305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) Calcium Carbonate420 mg
    Inactive Ingredients
    Ingredient NameStrength
    Aspartame (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Magnesium Stearate (UNII: 70097M6I30)  
    MINT (UNII: FV98Z8GITP)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code AZ;036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48083-305-2725 in 1 BOX12/29/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:48083-305-3050 in 1 BOX12/29/2017
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:48083-305-33125 in 1 BOX12/29/2017
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:48083-305-36250 in 1 BOX12/29/2017
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:48083-305-39500 in 1 BOX12/29/2017
    52 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:48083-305-411000 in 1 BOX12/29/2017
    62 in 1 POUCH; Type 0: Not a Combination Product
    7NDC:48083-305-3150 in 1 BOX12/29/2017
    72 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33112/29/2017
    Labeler - Certified Safety Manufacturing (788460483)
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