Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-995-60, 49035-995-62 - Packager: Wal-Mart Stores, Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated September 11, 2019
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- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- ASK A DOCTOR BEFORE USE IF
- 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
- QUESTIONS OR COMMENTS?
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-995 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) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 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:49035-995-62 3 in 1 CARTON 09/30/2015 1 NDC:49035-995-60 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202039 09/30/2015 Labeler - Wal-Mart Stores, Inc (051957769) Establishment Name Address ID/FEI Business Operations Aurolife Pharma, LLC 829084461 MANUFACTURE(49035-995)