Indications and uses
Relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms
GENDOSE - Sodium Bicarbonate 10 gr (650 mg) TABLETS (77333-831)
- Manufacturer
- Gendose Pharmaceuticals, LLC
- Effective date
- 2024-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:12:00
Label at a glance#
ProductSodium Bicarbonate 10 GR. (650 MG)
Active ingredientSODIUM BICARBONATE
Label structure8 sections
Dosage and administration
Adults: Take 1 tablet, dissolved in a glass of water, as needed. Maxlmum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking. D0 NOT EXCEED RECOMMENDED DOSE. Not recommended for children.
Storage and handling
each tablet contains : sodium 178 mg (7.74 meg) store at room temperature 15°-30°C (59°-86°F)
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Sodium bicarbonate 10 gr. (650 mg)
Purpose
Antacid
Uses
Relieves
- acid indigestion
- heartburn
- sour stomach
- upset stomach associated with these symptoms
Warnings
OTC - DO NOT USE SECTION
- Do not use this product if you are on a sodium-restricted diet unless directed by a doctor. Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age or older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product
WARNINGS AND PRECAUTIONS SECTION
- Stomach Warning: TO AVOID SERIOUS INJURY, D0 NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.
DRUG INTERACTIONS SECTION
- Drug Interaction Precaution: Ask a physician or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Directions
Adults: Take 1 tablet, dissolved in a glass of water, as needed. Maxlmum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking.
D0 NOT EXCEED RECOMMENDED DOSE. Not recommended for children.
Other information
- each tablet contains : sodium 178 mg (7.74 meg)
- store at room temperature 15°-30°C (59°-86°F)
Inactive ingredients
Pregelatinized starch, NF and mineral oil, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| SODIUM CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77333-831-10 | 2024-05-02 | C162847 | 48780-1 | 1030e365-66ce-111a-e063-dadaa90a10e2 | GENDOSE - Sodium Bicarbonate 10 gr (650 mg) TABLETS (77333-831) |
| 77333-831-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-66ce-111a-e063-dadaa90a10e2 | GENDOSE - Sodium Bicarbonate 10 gr (650 mg) TABLETS (77333-831) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77333-831-10 | Sodium Bicarbonate10 GR. (650 MG) | 100 in 1 BOX | TABLET | 100 | 3 | |
| 77333-831-25 | Sodium Bicarbonate10 GR. (650 MG) | 1 in 1 BLISTER PACK | TABLET | 1 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 77333-831-10 | EA - Each | 77333-831 | bea49102-7fce-4a53-aa2c-6730243462f3 | 1 | 2022-12-07 |
| 77333-831-25 | EA - Each | 77333-831 | c00fb374-0c7b-446e-a2de-8ccd9df55b06 | 1 | 2022-12-07 |
Products#
Every source-derived product name is available through these pages.
- Sodium Bicarbonate 10 GR. (650 MG)
- Sodium Bicarbonate
- STARCH, CORN
- MINERAL OIL
- SODIUM CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77333-831 | 77333-831-25, 77333-831-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| MINERAL OIL | T5L8T28FGP | 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 |
|---|---|---|---|---|---|---|
| 0e765edc-2647-533a-e063-6394a90a7c53 | ee90d829-9f1f-52ae-e053-2995a90a29ce | 2024-01-08 | Warnings | 0e765edc-2647-533a-e063-6394a90a7c53 ee90d829-9f1f-52ae-e053-2995a90a29ce |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.