Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 71610-041-30, 71610-041-60 - Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 45802-571
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 22, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
kidney disease. Your doctor should determine if you need a different dose.
When using this product
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- do not take more than directed
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- do not take at the same time as aluminum or magnesium antacids
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- do not take with fruit juices (see Directions)
- Directions
- 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 180 mg 30 71610-041-30 90 71610-041-60 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
20180222DKJ - PRINCIPAL DISPLAY PANEL - 180mg
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-041(NDC:45802-571) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color ORANGE (peach) Score no score Shape ROUND Size 12mm Flavor Imprint Code 93;7253 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71610-041-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2018 2 NDC:71610-041-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076447 04/22/2011 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-041)