Label: ALLERGY RELIEF- fexofenadine hydrochloride tablet
- NDC Code(s): 62011-0409-1, 62011-0409-2, 62011-0409-3
- Packager: Strategic Sourcing Services, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 22, 2021
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
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Warnings
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)
- Directions
- Other information
- Inactive ingredients
- Questions?
- Carton Label
- Carton
- Container Label
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
fexofenadine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0409 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) magnesium stearate (UNII: 70097M6I30) mannitol (UNII: 3OWL53L36A) POWDERED CELLULOSE (UNII: SMD1X3XO9M) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) FERROSOFERRIC OXIDE (UNII: XM0M87F357) polyethylene glycol 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK Score no score Shape OVAL Size 7mm Flavor Imprint Code 194;R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0409-2 1 in 1 CARTON 09/09/2019 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:62011-0409-1 3 in 1 CARTON 09/09/2019 2 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:62011-0409-3 70 in 1 CARTON 08/06/2020 3 70 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 ANDA076502 09/09/2019 Labeler - Strategic Sourcing Services, LLC (116956644)