Search by Drug Name or NDC
NDC 00904-7261-61 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 Major Pharmaceuticals. The primary component is SODIUM BICARBONATE.
Product Information
| NDC | 00904-7261 |
|---|---|
| Product ID | 0904-7261_ebf340c9-0b6e-13d2-e053-2995a90ae338 |
| Associated GPIs | |
| 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 | Major Pharmaceuticals |
| 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 FINAL |
| Application Number | part331 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00904-7261-61 (00904726161)
| NDC Package Code | 0904-7261-61 |
|---|---|
| Billing NDC | 00904726161 |
| Package | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-7261-61) / 10 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2022-10-26 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.01427 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | SODIUM BICARB 650 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL ebf340c9-0b6d-13d2-e053-2995a90ae338 Details
Uses
SPL UNCLASSIFIED SECTION
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.
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
Other information
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Unit Dose
Sodium Bicarbonate
DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
www.majorpharmaceuticals.com
WARNING: This product can expose you to chemicals including
lead, which is known to the State of California to cause cancer
and birth defects or other reproductive harm. For more information
go to www.P65Warnings.ca.gov.
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| SODIUM BICARBONATE
sodium bicarbonate tablet |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Major Pharmaceuticals (191427277) |