Label: SODIUM BICARBONATE tablet

  • NDC Code(s): 69367-258-10
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Sodium Bicarbonate 10 gr (650 mg)

  • Purpose

    Antacid

  • Uses

    relieves

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • Warnings

    Do not use this product if you are on a sodium-restricted diet unless directed by a doctor. Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

    Stomach Warning

    TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK.

    Consult a doctor if severe stomach pain occurs after taking this product.

    Drug Interaction Precaution

    Ask a physician or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Adults

    Take 1 tablet, dissolved in a glass of water, as needed. Maximum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking.

    DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

  • Other information

    • each tablet contains: sodium 178 mg (7.74 mEq)
    • store at room temperature 15º-30ºC (59º-86°F) in a well-closed container as defined in the USP
  • Inactive ingredients

    Microcrystalline cellulose and stearic acid

  • Questions or comments?

    Call 1-844-221-7294 M-F (9 a.m. to 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label

    NDC 69367-258-10

    Sodium Bicarbonate
    Tablets, USP

    10 gr (650 mg)

    ANTACID

    THIS PACKAGE FOR HOUSEHOLDS
    WITHOUT YOUNG CHILDREN.

    1000 Tablets

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-258
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE650 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S65
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-258-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00110/10/2022
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
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