Label: HUMCO SODIUM BICARBONATE- sodium bicarbonate powder

  • NDC Code(s): 0395-2685-01, 0395-2685-94
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 15, 2023

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  • SPL UNCLASSIFIED SECTION


    Drug Facts

  • Active Ingredient

    Soduim Bicarbonate, USP

  • Purpose

    Antacid

  • Use

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

  • Warnings NOT FOR INJECTIONS

    Except under supervision of a doctor do not administer to children under 6 years of age.

    Do not take more than six, 1/2 tsp. per person up to 60 years old, or three 1/2 tsp. per person 60 years or older in a 24 hour period.

    Do not use this product if you are on a sodium restricted diet (each 1/2 tsp. contains 30 mEq (0.7 g) Sodium).

    Do not use the maximum does more than 2 weeks.

  • Ask a doctor or pharmacist before use if

    you are currently taking a prescription drug. Antacids may interact with certain prescription drugs.

  • Keep out of reach of children.

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

  • Directions

    Adult and children 6 yrs of age and older:

    Take 1/2 tsp. in 1/2 glass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by doctor.

  • Inactive ingredients

    none

  • Packae Principal Display Pannel

    Label 4 oz

    image description

  • Principal Display Pannel

    Label 16 oz

    image description

  • New Label

    New Label

  • INGREDIENTS AND APPEARANCE
    HUMCO SODIUM BICARBONATE 
    sodium bicarbonate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-2685
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE1000 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-2685-94113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2017
    2NDC:0395-2685-01454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00103/25/1998
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(0395-2685) , manufacture(0395-2685) , pack(0395-2685) , analysis(0395-2685)
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