Indications and uses
relieves: • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms
Sodium Bicarbonate 5gr (325mg)
- Manufacturer
- Pharmaceutica North America, Inc. | Pure Source, LLC
- Effective date
- 2025-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:46:57
Label at a glance#
ProductSodium Bicarbonate 5gr (325mg)
Active ingredientSODIUM BICARBONATE
Label structure8 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
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Sodium bicarbonate 5 gr (325 mg)
Purpose
Antacid
Uses
relieves:
• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms
Warnings
Ask a doctor before use if you havea sodium restricted diet.
Ask a doctor or pharmacist before use if you aretaking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor ifsymptoms last more than 2 weeks
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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 89 mg
• store in a dry place at 15° – 30°C (59° – 86°F).
Inactive Ingredients
croscarmellose sodium, microcrystalline cellulose, silica, stearic acid, talc.
Product label
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45861-080-10 | EA - Each | 45861-080 | 52987c96-e151-43f0-ab34-cf752cc21d9f | 1 | 2025-05-14 |
Products#
Every source-derived product name is available through these pages.
- Sodium Bicarbonate 5gr (325mg)
- SODIUM BICARBONATE
- CROSCARMELLOSE SODIUM
- CELLULOSE, MICROCRYSTALLINE
- STEARIC ACID
- SILICON DIOXIDE
- TALC
- SODIUM CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45861-080 | 45861-080-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 471bf73e-f3f7-87b1-e063-6294a90aa20a | 4523b583-00d7-4cea-9e26-e7fd9f193191 | 2025-12-29 | Warnings | 471bf73e-f3f7-87b1-e063-6294a90aa20a 4523b583-00d7-4cea-9e26-e7fd9f193191 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.