Label: CALCIUM CARBONATE suspension

  • 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 28, 2021

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL teaspoonful)

    Calcium Carbonate 1250 mg (Equivalent to 500 mg elemental Calcium)

  • Purpose

    Antacid

  • Uses

    relieves:

    • heartburn
    • acid indigestion
    • sour stomach
    • 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 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

    Keep out of reach of children.

  • Directions

    • Shake well before using.
    • Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.
  • Other information

    • store at 20° to 25°C (68° to 77°F)
    • do not freeze
    • packaged with tamper evident seal
  • Inactive ingredients

    calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

  • Questions?

    Call 1-800-845-8210.

  • CALCIUM CARBONATE SUSPENSION

    image description
  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 
    calcium carbonate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-3117(NDC:0121-0766)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1250 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propylparaben (UNII: Z8IX2SC1OH)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    Saccharin Calcium (UNII: 5101OP7P2I)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-3117-3 5 mL in 1 CUP; Type 0: Not a Combination Product01/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33112/01/2004
    Labeler - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL(17856-3117) , REPACK(17856-3117)
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!