Label: SODIUM BICARBONATE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 71610-445-53, 71610-445-60, 71610-445-80 - Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 10135-685
- 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 July 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
SODIUM BICARBONATE - sodium bicarbonate tablet
Marlex Pharmaceuticals, Inc.
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.
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Sodium Bicarbonate
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
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Directions
- do not use the maximum dosage for more than 2 weeks
- dissolve tablets completely in water prior to use
325mg,
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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
650mg,
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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
- do not use the maximum dosage for more than 2 weeks
- Other information
- Inactive ingredients
- Questions or comments?
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Repackaging Information
Please reference the How Supplied section 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 71610-445-53 90 71610-445-60 180 71610-445-80 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
20200723JH - PRINCIPAL DISPLAY PANEL - 650 mg
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INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE
sodium bicarbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-445(NDC:10135-685) 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 STARCH, CORN (UNII: O8232NY3SJ) MINERAL OIL (UNII: T5L8T28FGP) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code G57 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71610-445-53 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 2 NDC:71610-445-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 3 NDC:71610-445-80 180 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 03/01/2020 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-445)
