Indications and uses
relieves: acid indigestion heartburn sour stomach upset stomach associated with these symptoms
Sodium Bicarbonate Antacid
- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Effective date
- 2026-03-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:51:13
Label at a glance#
ProductSodium Bicarbonate Antacid
Active ingredientSODIUM BICARBONATE
Label structure11 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.rugbylaboratories.com
www.rugbylaboratories.com
www.rugbylaboratories.comLabel contents#
Full prescribing information#
Drug Facts
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
Do not takemore than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 yeasr 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 havea sodium restricted diet.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you aretaking a prescription drug.
Antacids may interact with certain prescription drugs.
OTC - STOP USE SECTION
Stop use and ask a doctor ifsymptoms 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 accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
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 at room temperature 15º - 30º C (59º - 86º F)
Inactive ingredients
croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc
Questions or comments?
1-800-645-2158
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Rev. 12/16 R-29
Repackaging Information
Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
10gr (650mg)
NDC 71610-669-53, Bottles of 60 Tablets
NDC 71610-669-60, Bottles of 90 Tablets
NDC 71610-669-80, Bottles of 180 Tablets
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20260323BSC
PRINCIPAL DISPLAY PANEL - 650 mg
NDC 71610-669 - Sodium Bicarbonate 10gr (650 mg) Tablets
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| SODIUM CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | (716)10066953 | 71610-0669-53.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71610-669-53 | Sodium Bicarbonate Antacid | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 71610-669-60 | Sodium Bicarbonate Antacid | 90 in 1 BOTTLE | TABLET | 90 | 3 | |
| 71610-669-80 | Sodium Bicarbonate Antacid | 180 in 1 BOTTLE | TABLET | 180 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71610-669-53 | EA - Each | 71610-669 | e270c206-e85f-41a5-9cc6-b69159cea1d2 | 1 | 2022-12-07 |
| 71610-669-60 | EA - Each | 71610-669 | 1c12a94b-838e-40b3-a4ca-984062c35d79 | 1 | 2022-12-07 |
| 71610-669-80 | EA - Each | 71610-669 | d6112a07-9774-4bd7-b33b-45bf0e2e8823 | 1 | 2022-12-07 |
| 0536-1047-10 | EA - Each | 0536-1047 | fe82f6ce-ce8f-4ece-9ce3-f295a564ef98 | 1 | 2015-06-09 |
Products#
Every source-derived product name is available through these pages.
- Sodium Bicarbonate Antacid
- Sodium Bicarbonate
- CROSCARMELLOSE SODIUM
- CELLULOSE, MICROCRYSTALLINE
- STEARIC ACID
- SILICON DIOXIDE
- TALC
- SODIUM CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71610-669 | 71610-669-53, 71610-669-60, 71610-669-80 |
| 0536-1047 |
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 |
|---|---|---|---|---|---|---|
| Sodium Bicarbonate Antacid | SODIUM BICARBONATE | Aphena Pharma Solutions - Tennessee, LLC | bba7d5bf-c94b-4ee4-a399-9a2818d84c78 | 2026-03-23 | Warnings | 71610-669-53 71610-669-60 71610-669-80 71610-669 71610066960 71610066953 71610066980 4db6a586-dc28-33bb-e063-6394a90abc9b bba7d5bf-c94b-4ee4-a399-9a2818d84c78 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.