Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
- NDC Code(s): 68210-4090-1
- Packager: SPIRIT PHARMACEUTICALS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 13, 2024
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- Active ingredient (in each caplet)
- Purpose
- Uses
- Do not use if
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant and breast-feeding,
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4090 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink, pink (Peach/Orange colored, debossed with '180' on one side) Score 2 pieces Shape OVAL (Capsule shaped, biconvex film coated tablets) Size 17mm Flavor Imprint Code SG;202 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4090-1 100 in 1 PACKAGE; Type 0: Not a Combination Product 07/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204507 07/02/2020 Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)