Label: SODIUM BICARBONATE 5 GR- sodium bicarbonate tablet, soluble
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Contains inactivated NDC Code(s)
NDC Code(s): 69618-035-10 - Packager: Reliable 1 Laboratories LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 9, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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: 2-8 tablets every 4 hours, not more than 24 tablets in 24 hours
- adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE 5 GR
sodium bicarbonate tablet, solubleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-035 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 324 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code AP120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69618-035-10 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)