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 Cardinal Health 107, 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.
Active Ingredient
Drug Facts
In each tablet: Sodium Bicarbonate 10 gr (650 mg)
Purpose
Antacid
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.
Uses
Indications: Relieves ·acid indigestion ·heartburn ·sour stomach ·upset stomach associated with these symptoms
Warnings
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 the 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: 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 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.
Inactive Ingredients
Pregelatinized starch, NF and mineral oil, USP.
Other
·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.
Questions ? 1-815-877-6480
Manufactured For and Distributed By: Hospak® Unit Dose Products, Huntley, IL 60142
Distributed By:
Cardinal Health
Dublin, OH 43017
L40866170518
Rev. 8/17
Principal Display Panel
Sodium Bicarbonate
10 gr (650 mg)
Antacid Tablets
10 Tablets
* Please review the disclaimer below.
