Indications and uses
relieves: acid indigestion heartburn sour stomach upset stomach associated with these symptoms
Sodium Bicarbonate - Major Pharmaceuticals
- Manufacturer
- Major Pharmaceuticals
- Effective date
- 2026-09-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-09-26 01:01:14
Label at a glance#
ProductSodium Bicarbonate
Active ingredientSODIUM BICARBONATE
Label structure10 sections
Dosage and administration
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
Contacts and useful links#
Websitewww.major-rugby.com
www.major-rugby.com
www.major-rugby.comWebsitewww.p65warnings.ca.gov
www.P65Warnings.ca.gov
www.P65Warnings.ca.govLabel contents#
Full prescribing information#
Drug Facts
Active ingredient (in each tablet)
Sodium bicarbonate 10 gr (650 mg)
OTC - PURPOSE SECTION
Purpose
Antacid
Uses
relieves:
acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms
WARNINGS SECTION
Warnings
OTC - DO NOT USE 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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have a sodium restricted diet.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms last more than 2 weeks.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
each tablet contains: sodium 178 mg
store in a dry place at 15° – 30°C (59° – 86°F)
Inactive ingredients
croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc
Questions or comments?
1-800-231-4670
SPL UNCLASSIFIED SECTION
DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.
RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION.
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
WARNING: This product can expose you to chemicals including lead and mercury, which are known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Rev. 06/26 M-29 Re-order No. 701316
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0904-7261-61
MAJOR®
sodium bicarbonate
sodium bicarbonate
10 gr (650 mg)
antacid
100 tablets
(10 x 10) unit dose
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0309047261611 | GTIN-13: 0309047261611 EAN-13: 0309047261611 GTIN-12: 309047261611 UPC-A: 309047261611 GTIN storage (14 digits): 00309047261611 | 4624-100BC-Major-GI2_IFC R54864.jpg |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7261-61 | EA - Each | 0904-7261 | 12c9d63e-c7b6-4a45-b31d-ec8a7bcd7e18 | 1 | 2022-12-07 |
Products#
Every source-derived product name is available through these pages.
- Sodium Bicarbonate
- SODIUM CATION
- CROSCARMELLOSE SODIUM
- TALC
- MICROCRYSTALLINE CELLULOSE
- STEARIC ACID
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-7261 | 0904-7261-61 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BICARBONATE | 8MDF5V39QO | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2024-12-06 | full-release | 2026-06-01 00:41:12 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 289e96ec-d8d1-ee93-e063-6394a90a38d7 | ebf340c9-0b6d-13d2-e053-2995a90ae338 | 2024-12-06 | Warnings | ebf340c9-0b6d-13d2-e053-2995a90ae338 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.