Drug Facts
Active Ingredient (in each tablet)
Sodium bicarbonate 10 gr (650 mg)
Sodium Bicarbonate Tablet
FDA Label NDC 43353-162
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Sodium Bicarbonate (NDC 43353-162). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, indications:, ask a doctor or pharmacist, directions:, other information:, inactive ingredient, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Indications:
Relieves:
- acid indigestion
- heartburn
- sour stomach
- upset stomach associated with these symptoms
Ask A Doctor Or Pharmacist
- if you are on a sodium-restricted diet.
- if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
- if symptons last more than 2 weeks
Directions:
- Adults 60years of age and over - 1-2 tablets every 4 hours. Not more than 12 tablets in 24 hours
- Adults under 60 years- 1-4 tablets every4 hours. Not more than 24 tablets in 24 hours
- Dissolve tabelt completely in water before drinking.
- DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.
Other Information:
- each tablet contains: sodium 178 mg
- store at room temperature 15 °- 30 °C (59 °- 86 °F).
Inactive Ingredient
croscarmellose sodium, microcrystalline cellulose, stearic acid
Questions Or Comments
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
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 | 650 mg |
| 60 | 43353-162-53 |
| 90 | 43353-162-60 |
| 120 | 43353-162-70 |
| 180 | 43353-162-80 |
| 200 | 43353-162-85 |
| 360 | 43353-162-94 |
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:
Aphena Pharma Solutions (TN)
Cookeville, TN 38506
20171213JH
Principal Display Panel - 650 Mg
NDC 43353-162 - Sodium Bicarbonate 650 mg - Rx Only
Bottle Label 650 mg (43353 162 53)
* Please review the disclaimer below.
