Label: SODIUM BICARBONATE 10 GR. (650 MG)- sodium bicarbonate tablet
- NDC Code(s): 77333-827-10, 77333-827-25
- Packager: Gendose Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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.
- 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
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE 10 GR. (650 MG)
sodium bicarbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77333-827 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 650 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code S65 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77333-827-10 100 in 1 BOX 03/14/2023 1 NDC:77333-827-25 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/14/2023 Labeler - Gendose Pharmaceuticals, LLC (080257510)
