Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 60000-409-30, 60000-409-45, 60000-409-48, 60000-409-53 - Packager: Ahold U.S.A., Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 11, 2019
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
- 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
- Questions or comments?
- Principal Display Panel (180 mg 15 ct)
- Principal Display Panel (180 mg 30 ct)
- Principal Display Panel (180 mg 45 ct)
- Principal Display Panel (180 mg 45 ct+ 50% bonus)
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60000-409 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:60000-409-48 1 in 1 CARTON 01/15/2015 1 45 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:60000-409-30 1 in 1 CARTON 01/15/2015 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:60000-409-53 1 in 1 CARTON 01/15/2015 3 15 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:60000-409-45 1 in 1 CARTON 01/15/2015 4 45 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 - Ahold U.S.A., Inc (188910863) Establishment Name Address ID/FEI Business Operations Aurolife Pharma, LLC 829084461 MANUFACTURE(60000-409)