Label: SODIUM BICARBONATE 5 GR- sodium bicarbonate tablet

  • NDC Code(s): 70795-1130-0, 70795-1130-5
  • Packager: GRAXCELL PHARMACEUTICAL, LLC
  • Category: HUMAN OTC DRUG LABEL

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 21, 2021

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  • Active ingredient (in each tablet)

    Sodium bicarbonate 5 gr (325 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 or 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

    Drug Interaction Precaution

    Stomach Warning

    • TO AVOID SERIOUS INJURY, D0 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. Maxlmum 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.

    D0 NOT EXCEED RECOMMENDED DOSE

    Not recommended for children.

  • Other information

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

    Pregelatinized starch, NF and mineral oil, USP

  • Questions or comments?

    Call toll free 1-888-266-8818

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL

    Label

    Label 1

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 5 GR 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code G37
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70795-1130-5500 in 1 BOTTLE; Type 0: Not a Combination Product10/02/2017
    2NDC:70795-1130-01000 in 1 BOTTLE; Type 0: Not a Combination Product10/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/02/2017
    Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)
    Establishment
    NameAddressID/FEIBusiness Operations
    GRAXCELL PHARMACEUTICAL, LLC056556923manufacture(70795-1130)