Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
- NDC Code(s): 68210-5034-1
- 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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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet) Fexofenadine HCI 180 mg
- PurposeAntihistamine
- Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat
- Warnings Do not useif you have ever had an allergic reaction to this product or any of its ingredients.
- Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
- When using this product ■ do not take more than directed ■ do not take at the same time as aluminum or magnesium antacids ■ do not take with fruit juices (see Directions)
- Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.
- If pregnant or breast-feeding,ask a health professional before use
- Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222
- Directions adults and children 12 years and over take one 180 mg caplet with water once a day; do not take more than 1 caplet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
- Other information ■ store between 20º and 25ºC (68º and 77ºF) ■ protect from excessive moisture
- Inactive ingredients colloidal anhydrous silica, colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, titanium dioxide
- Questions or comments?1-888-333-9792
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-5034 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (Peach) Score no score Shape CAPSULE Size 17mm Flavor Imprint Code 180 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-5034-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210137 03/22/2024 Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
