Label: SODIUM BICARBONATE 10 GR (650 MG)- sodium bicarbonate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 1, 2025

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  • 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 takemore 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.
  • Ask a doctor before use if you have

    a sodium restricted diet.

  • Ask a doctor or pharmacist before use if you are

    taking a presciption drug. Antacids may intract 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.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately (1-800-222-1222).

  • 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
  • Other information

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

    Microcrystalline cellulose, stearic acid.

  • SPL UNCLASSIFIED SECTION

    TEMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

    Distributed by:

    ADVANCED RX LLC

    1942 NE 163rd St North Miami Beach,

    FL33162 U.S.A

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE   10 GR (650 MG)
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-611
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE650 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code SB6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-611-02200 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00109/01/2025
    Labeler - Advanced Rx LLC (042795108)
    Registrant - Advanced Rx LLC (042795108)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ocean Healthcare Pvt Ltd873673519manufacture(80513-611)
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