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NDC 71610-0438-94 Sodium Bicarbonate 650 mg/1 Details
Sodium Bicarbonate 650 mg/1
Sodium Bicarbonate is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is SODIUM BICARBONATE.
MedlinePlus Drug Summary
Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic in certain conditions. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 71610-0438-94Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate
Product Information
| NDC | 71610-0438 |
|---|---|
| Product ID | 71610-438_8c2fd216-d341-4bfb-a25b-6e04602d34bb |
| 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 |
| 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 71610-0438-94 (71610043894)
| NDC Package Code | 71610-438-94 |
|---|---|
| Billing NDC | 71610043894 |
| Package | 360 TABLET in 1 BOTTLE (71610-438-94) |
| Marketing Start Date | 2020-06-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f7ebb41a-d483-442a-95a0-47706cf3ee9a Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
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.
Ask a doctor before use if you have a sodium restricted diet.
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks
If pregnant or breast-feeding, ask a health professional before use.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- do not use the maximum dosage for more than 2 weeks
- tablets may be swallowed whole or dissolved in water prior to use
- 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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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 | 10 gr |
| 60 | 71610-438-53 |
| 90 | 71610-438-60 |
| 120 | 71610-438-70 |
| 180 | 71610-438-80 |
| 360 | 71610-438-94 |
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
20200706JH
INGREDIENTS AND APPEARANCE
| SODIUM BICARBONATE
sodium bicarbonate tablet |
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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(71610-438) | |