Label: SODIUM BICARBONATE 10 GR- sodium bicarbonate tablet, soluble
-
Contains inactivated NDC Code(s)
NDC Code(s): 69618-034-10 - Packager: Reliable 1 Laboratories LLC
- Category: HUMAN OTC DRUG LABEL
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 October 27, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- do not use the maximum dosage for more than 2 weeks
- dissolve tablets completely in water prior to use
- adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tabelts in 24 hours
- adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE 10 GR
sodium bicarbonate tablet, solubleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-034 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 648 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code AP119 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69618-034-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 11/01/2015 Labeler - Reliable 1 Laboratories LLC (079718111)