Active Ingredient (In Each Tablet)
Sodium bicarbonate 10 gr. (650 mg)
Sodium Bicarbonate Tablet
FDA Label NDC 77333-827
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Sodium Bicarbonate (NDC 77333-827). 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 active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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 (0R 12 TABLETS FOR ADULTS 60 YEARS OF AGE AND OLDER) IN A 24 HOUR PERIOD NOR USE MAXIMUM DOSAGE FOR MORE THAN 2 WEEKS, EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.
- ASK A DOCTOR BEFORE USE IF YOU HAVE A SODIUM RESTRICTED DIET.
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING A PRESCRIPTION DRUG. ANTACIDS MAY INTERACT WITH CERTAIN PRESCRIPTION DRUGS.
- STOP USE AND ASK A DOCTOR IF SYMPTOMS LAST MORE THAN 2 WEEKS.
- IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
Otc - Keep Out Of Reach Of Children
- KEEP OUT OF REACH OF CHILDREN. 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 (7.74 mEq)
- store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE, STEARIC ACID, MAGNESIUM STEARATE
* Please review the disclaimer below.
