Label: SODIUM BICARBONATE- sodium bicarbonate tablet, orally disintegrating
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NDC Code(s):
43353-041-53,
43353-041-60,
43353-041-70,
43353-041-80, view more43353-041-85, 43353-041-94
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 64980-182
- 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 18, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Indications:
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Warnings
Do not use this product if you are on a sodium-restricted diet unless directed by a doctor. Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24-hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.
- Stomach Warning:
- INDICATIONS & USAGE
- Drug Interaction Precaution:
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Directions:
Adults -Take 1 tablet, dissolved in a glass of water, as needed. • Maximum daily dose for adults up to 60 years of age is 24 tablets. • Maximum daily dose for adults 60 years of age or older is 12 tablets. • Dissolve completely in water before drinking. • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.
- Other Information:
- Inactive Ingredients:
- KEEP OUT OF REACH OF CHILDREN
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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 650mg 60 43353-041-53 90 43353-041-60 120 43353-041-70 180 43353-041-80 200 43353-041-85 360 43353-041-94 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
20160628DH - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE
sodium bicarbonate tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43353-041(NDC:64980-182) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) 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 CL;206 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43353-041-53 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/14/2015 2 NDC:43353-041-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2015 3 NDC:43353-041-70 120 in 1 BOTTLE; Type 0: Not a Combination Product 06/16/2015 4 NDC:43353-041-80 180 in 1 BOTTLE; Type 0: Not a Combination Product 06/05/2015 5 NDC:43353-041-85 200 in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2015 6 NDC:43353-041-94 360 in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 06/26/2012 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(43353-041)