Label: 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 December 30, 2019

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

View All Sections
  • Active ingredient (per tablet)

    Calcium Carbonate USP 750 mg

  • Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses relieves

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

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

    When using this product

    • do not take more than 10 tablets in 24 hours
    • if pregnant do not take more than 6 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
  • Directions

    Keep out of reach of children.

    • adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor
    • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other information

    • each tablet contains: calcium 300 mg
    • store at room temperature 15°-30°C (59°-86°F)
  • Inactive ingredients

    dextrose, flavor (peppermint), magnesium stearate, maltodextrin

  • Questions or comments?

    Call toll free: 1-800-456-7077

  • Principal Display Panel - 750 mg Pouch Label

    Safetec
    of America, Inc.

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    Manufactured for Safetec of America, Inc.
    Buffalo NY 14215

    EXTRA STRENGTH

    Antacid

    Calcium Carbonate 750 mg

    2 Chewable Tablets

    Principal Display Panel - 750 mg Pouch Label
  • Principal Display Panel – 50 Count Carton

    Safetec®
    of America, Inc.

    *Compare to the active
    ingredient in TUMS® EX

    NDC 61010-4408-1

    Antacid

    Calcium Carbonate 750 mg – Extra Strength

    • Fast heartburn relief
    • Relieves acid indigestion

    TAMPER EVIDENT UNIT DOSE POUCHES

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    50 Pouches 2 Tablets per pouch

    Principal Display Panel – 50 Count Carton
  • Principal Display Panel – 100 Count Carton

    Safetec®
    of America, Inc.

    *Compare to the active
    ingredient in TUMS® EX

    NDC 61010-4408-2

    Antacid

    Calcium Carbonate 750 mg – Extra Strength

    • Fast heartburn relief
    • Relieves acid indigestion

    PUSH TO OPEN

    Dispense
    through opening

    TAMPER EVIDENT UNIT DOSE POUCHES

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    100 Pouches 2 Tablets per pouch

    Principal Display Panel – 100 Count Carton
  • INGREDIENTS AND APPEARANCE
    ANTACID 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4408
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUND (ROUND) Size16mm
    FlavorImprint Code AP;052
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4408-02 in 1 POUCH; Type 0: Not a Combination Product12/30/2019
    2NDC:61010-4408-150 in 1 BOX12/30/2019
    2NDC:61010-4408-02 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:61010-4408-2100 in 1 BOX12/30/2019
    3NDC:61010-4408-02 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/30/2019
    Labeler - Safetec of America, Inc. (874965262)
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!