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NDC 10135-0685-10 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 Marlex Pharmaceuticals Inc. 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: 10135-0685-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate
Product Information
| NDC | 10135-0685 |
|---|---|
| Product ID | 10135-685_8cebbe6f-e18b-4d3e-8512-8b2e61fc036b |
| 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 | Marlex Pharmaceuticals Inc |
| Pharmaceutical Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 10135-0685-10 (10135068510)
| NDC Package Code | 10135-685-10 |
|---|---|
| Billing NDC | 10135068510 |
| Package | 1000 TABLET in 1 BOTTLE (10135-685-10) |
| Marketing Start Date | 2020-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 36c01ccb-1129-4e7f-9014-86f6ec1c14de Details
SPL UNCLASSIFIED SECTION
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.
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Sodium Bicarbonate
Warnings
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
Questions or comments?
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| SODIUM BICARBONATE
sodium bicarbonate tablet |
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| SODIUM BICARBONATE
sodium bicarbonate tablet |
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| Labeler - Marlex Pharmaceuticals Inc (782540215) |
Revised: 5/2020
Document Id: 8cebbe6f-e18b-4d3e-8512-8b2e61fc036b
Set id: 36c01ccb-1129-4e7f-9014-86f6ec1c14de
Version: 2
Effective Time: 20200520