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

  • NDC Code(s): 77333-827-10, 77333-827-25
  • Packager: Gendose Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2024

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

  • 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 TAKE MORE THAN 24 TABLETS FOR ADULTS UP TO 60 YEARS OF AGE (0R 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 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.
  • 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)
  • INACTIVE INGREDIENTS

    MICROCRYSTALLINE CELLULOSE, STEARIC ACID, MAGNESIUM STEARATE

  • PRINCIPAL DISPLAY PANEL

    LBL

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE   10 GR. (650 MG)
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77333-827
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code S65
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77333-827-10100 in 1 BOX03/14/2023
    1NDC:77333-827-251 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00103/14/2023
    Labeler - Gendose Pharmaceuticals, LLC (080257510)