Label: SODIUM BICARBONATE ANTACID- sodium bicarbonate tablet
- NDC Code(s): 54738-035-03
- Packager: Richmond Pharmaceuticals, Inc.
- 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 November 1, 2017
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- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Keep out of reach of children
- Uses
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Warnings
Warnings
Ask a doctor before use if you have a sodium restricted diet
Ask a doctor or pharmacist before use of 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.
This package for households without young children.
Each tablet contains: sodium 89 mg
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Directions
Directions
- adults 60 years of age and over: 2-4 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
- do not use the maximum dosage for more than 2 weeks
- tablets may be swallowed whole or dissolved in water prior to use
- Inactive ingredients
- Storage
- Questions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE ANTACID
sodium bicarbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-035 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 325 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white Score no score Shape ROUND (Tablet) Size 9mm Flavor Imprint Code AP;120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54738-035-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 06/01/2015 Labeler - Richmond Pharmaceuticals, Inc. (043569607) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(54738-035)
