Label: FEXOFENADINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70518-2971-0, 70518-2971-1 - Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 55111-784
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 10, 2022
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
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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?
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PRINCIPAL DISPLAY PANEL
DRUG: Fexofenadine hydrochloride
GENERIC: Fexofenadine hydrochloride
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-2971-0
NDC: 70518-2971-1
COLOR: pink
SHAPE: OVAL
SCORE: No score
SIZE: 7 mm
IMPRINT: 194;R
PACKAGING: 100 in 1 BOTTLE, PLASTIC
PACKAGING: 30 in 1 BOTTLE, PLASTIC
ACTIVE INGREDIENT(S):
- Fexofenadine Hydrochloride 180mg in 1
INACTIVE INGREDIENT(S):
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- MANNITOL
- POWDERED CELLULOSE
- FD&C RED NO. 40
- HYPROMELLOSE 2910 (6 MPA.S)
- FERROSOFERRIC OXIDE
- POLYETHYLENE GLYCOL 400
- TITANIUM DIOXIDE
- STARCH, CORN
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-2971(NDC:55111-784) 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:70518-2971-0 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/16/2020 2 NDC:70518-2971-1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/27/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076502 12/16/2020 Labeler - REMEDYREPACK INC. (829572556)