Label: SODIUM BICARBONATE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 May 20, 2020

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  • SPL UNCLASSIFIED SECTION

    SODIUM BICARBONATE - sodium bicarbonate tablet

    Marlex Pharmaceuticals, Inc.      

    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.

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    Sodium Bicarbonate

  • Active ingredient (in each tablet)

    Sodium bicarbonate 10 gr (650 mg)

    Sodium bicarbonate 5gr (325 mg)

  • Purpose

    Antacid

  • Uses

    Relieves

    • acid indigestion heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • Warnings

    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.

  • Directions

    • do not use the maximum dosage for more than 2 weeks
    • dissolve tablets completely in water prior to use

    325mg,

    • adults 60 years of age and over: 2-8 tablets every 4 hours, not more than 24 tablets in 24 hours
    • adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours

    650mg,

    • 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 89mg (325mg) 
    • store at room temperature 15°-30°C (59°-86°F) in well-closed containers as defined in the USP

         sodium 178 mg (650mg) 

  • Inactive ingredients

    Pregelatinized starch, NF and mineral oil, USP

  •  Questions or comments?

    Call toll free 1-888-266-8818

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

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-684-10

    Marlex Pharmaceuticals, Inc.

    Sodium Bicarbonate

    Sodium Bicarbonate 5 gr (325 mg) Antacid

    1000 Tablets

    PRINCIPAL DISPLAY PANEL NDC 10135-684-10 Marlex Pharmaceuticals, Inc. Sodium Bicarbonate Sodium Bicarbonate 5 gr (325 mg) Antacid 1000 Tablets

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-685-10

    Marlex Pharmaceuticals, Inc.

    Sodium Bicarbonate

    Sodium Bicarbonate 10gr (650 mg) Antacid

    1000 Tablets

    PRINCIPAL DISPLAY PANEL NDC 10135-685-10 Marlex Pharmaceuticals, Inc. Sodium Bicarbonate Sodium Bicarbonate 10gr (650 mg) Antacid 1000 Tablets

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-684
    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
    ColorWHITEScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code G57
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-684-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33403/01/2020
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-685
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize11mm
    FlavorImprint Code G35
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-685-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33403/01/2020
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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