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 Westminster Pharmaceuticals, 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.

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Drug Facts


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

Otc - Do Not Use



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 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. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.


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



Ask a physician or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.


Otc - Keep Out Of Reach Of Children



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.


Adults



Take 1 tablet, dissolved in a glass of water, as needed. Maximum 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.

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 a well-closed container as defined in the USP

Inactive Ingredients



Microcrystalline cellulose and stearic acid


Questions Or Comments?



Call 1-844-221-7294 M-F (9 a.m. to 5 p.m. EST)


Principal Display Panel - 1000 Tablet Bottle Label



NDC 69367-258-10

Sodium Bicarbonate
Tablets, USP

10 gr (650 mg)

ANTACID

THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN.

1000 Tablets

Westminster
Pharmaceuticals


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