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 Ingenus Pharmaceuticals Nj, Llc. 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.

Drug Facts



Active Ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)


Indications:



Relieves:

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


Stomach Warning:



TO AVOID SERIOUS INJURY, DO 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:



Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.


Directions:



  • Adults - Take 1 tablet, dissolved in a glass of water, as needed.
  • Maximum daily dose for adults upto 60 years of age is 24 tablets.
  • Maximum daily dose for adults 60 years of age and older is 12 tablets.
  • Dissolve completely in water before drinking.
  • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Other Information:



  • each tablet contains: sodium 178 mg (7.74 meq)
  • 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 mieral oil, USP.


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