Label: MCKESSON ANTACID CALCIUM CARBONATE- calcium carbonate tablet, chewable

  • NDC Code(s): 68599-1411-3
  • Packager: McKesson Medical-Surgical
  • 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 March 14, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Calcium Carbonate 420 mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses

    Relieves

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

    Warnings

  • DO NOT USE

    Do not use

    • the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
    • have kidney disease
  • WHEN USING

    When using this product

    • do not take more than 19 tablets in a 24 hour period. If symptoms persist for more than 2 weeks, stop using this product and see a doctor.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    ​ Directions

    Adults and children: (12 years and older) Chew 2 tablets every 2 - 3 hours or as symptoms occu, repeat hourly if needed. Do not exceed 19 tablets in 24 hours.

    Children under 12 years: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • calcium content per tablet: 168 mg

    • Phenylketonurics: each tablet may contain 1.5 mg phenylalanine
    • store at room temperature 59-86°F (15-30°C) in a dry place
    • tamper-evident sealed packets
    • do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    aspartame, croscarmellose sodium, magnesium stearate, maltodextrin, mineral oil, mint flavor, sorbitol

  • QUESTIONS

    Questions or comments? Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    McKesson

    Antacid Tablets

    Calcium Carbonate 420 mg

    NDC 68599-1411-3

    Tablets for acid indigestion, gas, and heartburn.

    2 Per Pack

    250 Packs Per Box

    MFR #87675

    101R Antacid Label 4-13-21

  • INGREDIENTS AND APPEARANCE
    MCKESSON ANTACID CALCIUM CARBONATE 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-1411
    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)  
    SORBITOL (UNII: 506T60A25R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorMINTImprint Code AZ;036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-1411-3250 in 1 BOX07/01/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/01/2021
    Labeler - McKesson Medical-Surgical (023904428)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(68599-1411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794pack(68599-1411)
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