OTC Medication Information: Sodium Bicarbonate
SODIUM BICARBONATE- sodium bicarbonate tablet
Aphena Pharma Solutions — Tennessee, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
SODIUM BICARBONATE – sodium bicarbonate tablet
Marlex Pharmaceuticals, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Sodium Bicarbonate
Active ingredient (in each tablet)
Sodium bicarbonate 10 gr (650 mg)
Sodium bicarbonate 5gr (325 mg)
Purpose
Antacid
Uses
Relieves
- acid indigestion heartburn
- sour stomach
- upset stomach associated with these symptoms
Warnings
Ask a doctor before use if you have
a sodium restricted diet
Ask a doctor or p harmacist before use if you are
taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop use and ask a doc tor if
symptoms last more than 2 weeks
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Directions
- do not use the maximum dosage for more than 2 weeks
- dissolve tablets completely in water prior to use
325mg,
- adults 60 years of age and over: 2-8 tablets every 4 hours, not more than 24 tablets in 24 hours
- adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours
650mg,
- adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
- adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours
Other information
- each tablet contains: sodium 89mg (325mg)
- store at room temperature 15°-30°C (59°-86°F) in well-closed containers as defined in the USP
sodium 178 mg (650mg)
Inactive ingredients
Pregelatinized starch, NF and mineral oil, USP
Questions or comments?
Call toll free 1-888-266-8818
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
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 | 71610-445-53 |
90 | 71610-445-60 |
180 | 71610-445-80 |
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
20200723JH
PRINCIPAL DISPLAY PANEL — 650 mg
NDC 71610-445 — Sodium Bicarbonate 650 mg Tablets
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Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Aphena Pharma Solutions — Tennessee, LLC | 128385585 | REPACK (71610-445) |
Revised: 07/2020 Aphena Pharma Solutions — Tennessee, LLC
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/sodium-bicarbonate-8/