Label: SODIUM BICARBONATE tablet

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

Drug Label Information

Updated October 21, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts
    Active ingredients (in each tablet)

    Sodium Bicarbonate 10 gr (650mg)

  • 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 beforeuse 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?

    Phone +1-855-642-2594

  • SPL UNCLASSIFIED SECTION

    Rev.: 04/2022

    MADE IN USA

    Manufactured by:

    APNAR PHARMA LLP

    East Windsor

    NJ 08520

  • BOXED WARNING (What is this?)

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

  • Sodium Bicarbonate Tablets,USP 10gr (650mg)-1000 Tablets

    NDC : 24689-137-01

    Sodium
    Bicarbonate 10 gr TABLETS, USP
    Antacid

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

    1000 Tablets

    Label-Sodium Bicarbonate Tablets USP 650mg 1000s count

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-137
    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)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AS3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-137-011000 in 1 BOTTLE; Type 0: Not a Combination Product06/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00106/24/2022
    Labeler - APNAR PHARMA LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    INVAHEALTH INC116840615label(24689-137) , pack(24689-137)
    Establishment
    NameAddressID/FEIBusiness Operations
    APNAR PHARMA LLP118530917manufacture(24689-137) , analysis(24689-137) , pack(24689-137)