Label: PLUS PHARMA CALCIUM ANTACID- calcium carbonate tablet, chewable

  • 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 15, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient (in each tablet)

    Calcium Carbonate, USP 500 mg


  • Purpose

    Antacid


  • Uses

    for the relief of

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

  • Warnings

    Do not take more than 15 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.


    Ask a doctor or pharmacist before use if you are

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

    If pregnant or breast-feeding,

    ask a doctor before use.

    Keep out of reach of children.

  • Directions

    Adults and children 12 years and older
    Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a doctor

    Children under 12 years
    Do not give to children under 12 years unless directed by a doctor

  • Other information

    • Each tablet contains: Elemental Calcium 195 mg
    • Each tablet contains: Sugar 1g
    • Do not exceed recommended dosage
    • Store at room temperature in a dry place
    • Do not use if clear neck seal is broken or missing
  • Inactive ingredients

    Acacia, Artificial Cherry Flavor, Artificial Red Berry Flavor, Colloidal Silica, D and C Red #27 Lake, FD and C Blue #1 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural and Artificial Spearmint Flavor, Strach, Sucrose


  • Questions?

    If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.


  • HOW SUPPLIED

    Product: 50090-4478

    NDC: 50090-4478-0 150 TABLET, CHEWABLE in a BOTTLE, PLASTIC

  • CALCIUM CARBONATE

    Label Image
  • INGREDIENTS AND APPEARANCE
    PLUS PHARMA  CALCIUM ANTACID
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4478(NDC:51645-735)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorpink (cherry flavor) , white (spearmint flavor) , blue (grape flavor) Scoreno score
    ShapeROUND (flat faced beveled edge uncoated) Size16mm
    FlavorCHERRY (pink tablet) , SPEARMINT (white tablet) , GRAPE (blue tablet) Imprint Code GPI;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-4478-0150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/27/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/27/2006
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-4478)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!