Label: HUMCO DEWEES CARMINATIVE- magnesium carbonate suspension

  • NDC Code(s): 0395-0713-92
  • 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 December 7, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Magnesium Carbonate 250 mg per tsp. (5 mL)

  • Purpose

    Carminative

  • Use

    For the temporary relief of upset stomach or sour stomach, and acid indigestion.

  • Warnings

    Do not use if you have kidney desease.

  • When sing this product

    Do not take more than the maximum recommended daily dose (Adults 8 tsps. - children 4 tsps.), or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

    May have laxative effect.

  • Ask a doctor before use

    If you are taking prescription drugs. Antacids may interact with certain prescription drugs.

  • Keep out of reach of children.

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

  • Directions

    (Shake well before using)

    Follow dosage below or as directed by a doctor.

    Adults and children 12 yrs. and older: 2 tsps. every 3 to 4 hrs.

    Children 6 to 12 yrs. of age: 1 tsp. every 3 to 4 hrs.

    Children under 2 yrs. of age: consult a doctor before use.

  • Inactive ingredients

    Asafetida, Avicel, Benzyl Alcohol, Carrageenan, Glycerin, Purified Water, Simethicone, Sucrose, Xanthan Gum

  • Labels

    Old

    Old

  • New Label

    New

    New

  • INGREDIENTS AND APPEARANCE
    HUMCO DEWEES CARMINATIVE 
    magnesium carbonate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0713
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S) (UNII: 83D19O7250)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ASAFETIDA (UNII: W9FZA51AS1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-0713-9259 mL 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 finalpart33103/25/1998
    Labeler - Humco Holding Group, inc. (825672884)
    Registrant - Humco Holding Group, inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding group, Inc.825672884manufacture(0395-0713) , analysis(0395-0713) , pack(0395-0713) , label(0395-0713)