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
  • 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 6, 2017

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  • SPL UNCLASSIFIED SECTION


    Drug Facts

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  • Active Ingredient

    Soduim Bicarbonate, USP

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  • Purpose

    Antacid

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  • Use

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

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  • 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.

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  • Ask a doctor or pharmacist before use if

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

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  • Keep out of reach of children.

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

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  • 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.

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  • Inactive ingredients

    none

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  • Packae Principal Display Pannel

    Label 4 oz

    image description

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  • Principal Display Pannel

    Label 16 oz

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  • New Label
  • INGREDIENTS AND APPEARANCE
    HUMCO SODIUM BICARBONATE 
    sodium bicarbonate powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-2685
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 1000 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0395-2685-94 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017
    2 NDC:0395-2685-01 454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 03/25/1998
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    Name Address ID/FEI Business Operations
    Humco Holding Group, Inc. 825672884 label(0395-2685) , manufacture(0395-2685) , pack(0395-2685) , analysis(0395-2685)
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