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NDC 43353-0041-70 Sodium Bicarbonate 650 mg/1 Details
Sodium Bicarbonate 650 mg/1
Sodium Bicarbonate is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is SODIUM BICARBONATE.
Product Information
| NDC | 43353-0041 |
|---|---|
| Product ID | 43353-041_a33fd71a-4174-4989-82f2-6c8c39e187b3 |
| Associated GPIs | 48200010000325 |
| GCN Sequence Number | 002661 |
| GCN Sequence Number Description | sodium bicarbonate TABLET 650 MG ORAL |
| HIC3 | D4B |
| HIC3 Description | ANTACIDS |
| GCN | 07855 |
| HICL Sequence Number | 000523 |
| HICL Sequence Number Description | SODIUM BICARBONATE |
| Brand/Generic | Generic |
| Proprietary Name | Sodium Bicarbonate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium bicarbonate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, ORALLY DISINTEGRATING |
| Route | ORAL |
| Active Ingredient Strength | 650 |
| Active Ingredient Units | mg/1 |
| Substance Name | SODIUM BICARBONATE |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part331 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 43353-0041-70 (43353004170)
| NDC Package Code | 43353-041-70 |
|---|---|
| Billing NDC | 43353004170 |
| Package | 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-70) |
| Marketing Start Date | 2015-06-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7ac1638a-1b1f-4407-a8f4-190de4d58736 Details
Indications:
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:
Drug Interaction Precaution:
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:
SPL UNCLASSIFIED SECTION
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
INGREDIENTS AND APPEARANCE
| SODIUM BICARBONATE
sodium bicarbonate tablet, orally disintegrating |
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| Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 128385585 | REPACK(43353-041) | |