Drug Facts
Active ingredient (in each tablet)
Sodium bicarbonate 10 gr (650 mg)
Sodium Bicarbonate Antacid Tablet
FDA Label NDC 71610-669
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Sodium Bicarbonate Antacid (NDC 71610-669). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
relieves:
- acid indigestion
- heartburn
- sour stomach
- upset stomach associated with these symptoms
Warnings
Do not take more 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
Ask a doctor before use if you have a sodium restricted diet.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
Otc - Stop Use
Stop use and ask a doctor if symptoms last more than 2 weeks
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 15° - 30° C (59° - 86° F)
Inactive Ingredients
croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc
Questions Or Comments?
1-800-645-2158
Other
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 tablets. This drug product has been received by Aphena Pharma - TN 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:
| Count | 650 mg |
| 60 | 71610-669-53 |
| 90 | 71610-669-60 |
| 180 | 71610-669-80 |
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:
Aphena Pharma Solutions (TN)
Cookeville, TN 38506
20221018JK
Principal Display Panel - 650 Mg
NDC 71610-669 - Sodium Bicarbonate 650 mg Tablets
Bottle Label 650 mg (71610 0669 53)
* Please review the disclaimer below.
