Label: SODIUM BICARBONATE tablet

  • NDC Code(s): 64980-528-10
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2024

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  • BOXED WARNING (What is this?)

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • ACTIVE INGREDIENT

    Drug Facts
    Active ingredients (in each tablet)
    Sodium Bicarbonate 10 gr (650 mg)

  • PURPOSE

    Purpose
    Antacid

  • INDICATIONS & USAGE

    Uses: relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms

  • WARNINGS

    Warnings
    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 the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
    Ask a doctor before use if you have a sodium restricted diet.
    Ask a doctor or pharmacist before use if you are taking a prescription drug.
    Antacids may interact with certain prescription drugs.
    Stop use and ask a doctor if symptoms last more than 2 weeks
    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use the maximum dosage for more than 2 weeks
    • tablets may be swallowed whole or dissolved in water prior to use
    • adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
    • adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours
  • STORAGE AND HANDLING

    Other Information:  Each tablet contains: sodium 178 mg (7.74 mEq) • store at room temperature 15°-30°C (59°-86°F) in a well closed container as defined in the USP.

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Microcrystalline cellulose NF, Hydrogenated Vegetable oil NF

  • QUESTIONS

    Questions or Comments? 1-866-562-4597

  • SPL UNCLASSIFIED SECTION

    Issued: 08/2022

    Distributed by:
    Rising Pharmaceuticals, Inc.
    East Brunswick, NJ 08816

  • PRINCIPAL DISPLAY PANEL

    ———PRINCIPAL DISPLAY PANEL———

    Rising Pharmaceuticals Inc.                 NDC 64980-528-10

    Sodium Bicarbonate 10 gr (650 mg) TABLETS, USP
    Antacid

    THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

    1000 Tablets

    label

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64980-528
    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)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AS3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64980-528-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM001.3007/20/2020
    Labeler - Rising Pharma Holdings, Inc. (116880195)
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