Label: FEXOFENADINE HYDROCHLORIDE tablet
- NDC Code(s): 71309-091-01
- Packager: Safrel Pharmaceuticals, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 28, 2023
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- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
-
WARNINGS
Do not use
if 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 if
an 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
-
DIRECTIONS
adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)
take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg)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
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71309-091 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) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color orange (PEACH) Score no score Shape OVAL (Capsule-shaped) Size 17mm Flavor Imprint Code G6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71309-091-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211075 01/03/2021 Labeler - Safrel Pharmaceuticals, LLC. (080566287)
