Label: SODIUM BICARBONATE ANTACID- sodium bicarbonate tablet
- NDC Code(s): 71610-669-53, 71610-669-60, 71610-669-80
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 0536-1047
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 10, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
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Warnings
Do not takemore than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 yeasr of age and older) in a 24-hour period nor use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
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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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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Repackaging Information
Please reference the How Suppliedsection listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 650 mg 60 71610-669-53 90 71610-669-60 180 71610-669-80 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20221018JK - PRINCIPAL DISPLAY PANEL - 650 mg
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INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE ANTACID
sodium bicarbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-669(NDC:0536-1047) 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 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 Size 11mm Flavor Imprint Code CPC77 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71610-669-53 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2022 2 NDC:71610-669-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2022 3 NDC:71610-669-80 180 in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M001 03/25/2015 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 repack(71610-669)
