Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 68196-976-91 - Packager: Sam's West Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated September 10, 2019
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- Active ingredient(in each tablet)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- When using this product
- Stop use and ask doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-976 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE (Peach) Score no score Shape CAPSULE (Bevel Edge, Biconvex) Size 17mm Flavor Imprint Code E;44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68196-976-91 1 in 1 CARTON 01/15/2015 1 150 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202039 01/15/2015 Labeler - Sam's West Inc (051957769) Establishment Name Address ID/FEI Business Operations Aurolife Pharma, LLC 829084461 MANUFACTURE(68196-976)