Label: SODIUM BICARBONATE tablet
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NDC Code(s):
43353-162-53,
43353-162-60,
43353-162-70,
43353-162-80, view more43353-162-85, 43353-162-94
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 54738-020
- 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 December 13, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Indications:
- Warnings
- Directions:
- Other Information:
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENT
- 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 43353-162-53 90 43353-162-60 120 43353-162-70 180 43353-162-80 200 43353-162-85 360 43353-162-94 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
20171213JH - 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:43353-162(NDC:54738-020) 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) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (White) Score no score Shape ROUND (round) Size 11mm Flavor Imprint Code AP;119 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43353-162-53 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2016 2 NDC:43353-162-60 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/22/2016 3 NDC:43353-162-70 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/22/2016 4 NDC:43353-162-80 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2016 5 NDC:43353-162-85 200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/02/2016 6 NDC:43353-162-94 360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/22/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 05/01/2015 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(43353-162)