Label: ANTACID- calcium carbonate tablet

  • NDC Code(s): 69396-142-01, 69396-142-05
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 27, 2024

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  • Active Ingredient (in each tablet)

    Calcium Carbonate 420mg

  • Purpose

    Antacid

  • Uses

    Relieves

    • Heartburn
    • sour stomach
    • acid indigestion
    • upset stomach due to these symptoms

  • Directions

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

  • Warnings

  • Ask a doctor or pharmacist before use if you

    • have kidney disease
    • are taking a prescription drug
    • Antacids may interact with certain prescription drugs
  • Keep out of reach of children

    Keep out of reach of children

  • Other Information

    • Store at 15ºC - 30ºC (59ºF - 86ºF)
    • Calcium content per tablet: 168mg
    • Phenylketonurics: each tablet contains 1.5mg phenylalanine

    Do not use if packet is open or torn

    Tamper Evident

    Chewable

  • Inactive Ingredients

    Magnesium Stearate, Aspartame. Croscarmellose Sodium, Maltodextrin, mint flavor, sorbitol

  • Questions or Comments?

    Call 1-888-296-9067

  • 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 the advice and supervision of a doctor. If symptoms persist for more than two weeks, stop using this product and see a doctor.

  • Distributed By:

    Distributed By:

    Trifecta Pharmaceuticals USA®

    Ft. Lauderdale, FL. 33301 USA

    1-888-296-9067

    *This product is not manufactured or distributed by GSK, owner of the registered trademark Tums®

    Reorder No. 2016

  • PRINCIPAL DISPLAY PANEL

    CS 2016 Globe Antacid 50pk 031124 CDER

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-142
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SORBITOL (UNII: 506T60A25R)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINT (UNII: FV98Z8GITP)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize11mm
    FlavorMINTImprint Code AZ036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-142-0150 in 1 BOX08/08/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69396-142-0510000 in 1 BAG08/08/2023
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00108/08/2023
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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