Label: CALCIUM CARBONATE powder

  • NDC Code(s): 0395-0431-01
  • Packager: Humco Holding Group, Inc.
  • 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 June 19, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Calcium Carbonate

  • Purpose

    Antacid

  • Use

    For relief of heartburn, acid ingestion, and upset stomach associated with these symptoms.

  • Warnings

    Except under the supervision of a doctor:

    • do not administer to children under 6 years of age.
    • do not take more than 3 teaspoonfuls in a 24 hour period.
  • WHEN USING

    • do not use the maximum dosge of this product for more than 2 weeks except under the advice and supervision of a doctor or other health professional.
  • Ask a doctor before use

    if you are preganant or nursing a baby.

  • Keep out of reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control immediately.

  • Directions

    Adults and children 6 yrs. of age and older: Take 1/2 level tsp. in 1/2 glass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by a doctor.

  • Inactive Ingredients

    None

  • Principal Display Panel

    CalCarb.jpg

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 
    calcium carbonate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0431
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-0431-01454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-0431) , analysis(0395-0431) , pack(0395-0431) , label(0395-0431)