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 Aphena Pharma Solutions - Tennessee, 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 ingredients (in each tablet) Sodium Bicarbonate 10 gr (650mg) | Purpose Antacid |
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 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.
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.
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 mineral oil, USP.
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 650mg |
| 60 | 43353-041-53 |
| 90 | 43353-041-60 |
| 120 | 43353-041-70 |
| 180 | 43353-041-80 |
| 200 | 43353-041-85 |
| 360 | 43353-041-94 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20160628DH
Principal Display Panel
NDC 43353-041-53
Sodium
Bicarbonate
Antacid
60 Tablets
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