CALCIUM CARBONATE POWDER [HUMCO HOLDING GROUP, INC.]

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CALCIUM CARBONATE POWDER [HUMCO HOLDING GROUP, INC.]
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NDC 0395-0431-01
Set ID 8b207b49-d3fd-4108-b611-dca27c9dc78a
Category HUMAN OTC DRUG LABEL
Packager Humco Holding Group, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • 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)
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