FDA Label for Sodium Bicarbonate

View Indications, Usage & Precautions

Sodium Bicarbonate Product Label

The following document was submitted to the FDA by the labeler of this product Marlex Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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.


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?



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Principal Display Panel



NDC 10135-684-10

Marlex Pharmaceuticals, Inc.

Sodium Bicarbonate

Sodium Bicarbonate 5 gr (325 mg) Antacid

1000 Tablets

NDC 10135-685-10

Marlex Pharmaceuticals, Inc.

Sodium Bicarbonate

Sodium Bicarbonate 10gr (650 mg) Antacid

1000 Tablets


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