Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
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NDC Code(s):
71335-0483-1,
71335-0483-2,
71335-0483-3,
71335-0483-4, view more71335-0483-5, 71335-0483-6, 71335-0483-7
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 58602-711
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 19, 2020
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
- Warnings
- Do not use
- Ask a doctor before use if you have
- When using this product
- Stop use and ask doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
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Directions
adults and children 12 years of age and over take one 180 mg tablet with water once a day;
do not take more than 1 tablet in 24 hourschildren 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
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 tablet in 24 hourschildren 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?
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HOW SUPPLIED
Product: 71335-0483
NDC: 71335-0483-1 30 TABLET, FILM COATED in a BOTTLE
NDC: 71335-0483-2 15 TABLET, FILM COATED in a BOTTLE
NDC: 71335-0483-3 60 TABLET, FILM COATED in a BOTTLE
NDC: 71335-0483-4 90 TABLET, FILM COATED in a BOTTLE
NDC: 71335-0483-5 5 TABLET, FILM COATED in a BOTTLE
NDC: 71335-0483-6 180 TABLET, FILM COATED in a BOTTLE
NDC: 71335-0483-7 100 TABLET, FILM COATED in a BOTTLE
- Fexofenadine Hcl 180mg Tablet
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0483(NDC:58602-711) 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE (Peach) Score no score Shape CAPSULE (Bevel Edge, Biconvex) Size 17mm Flavor Imprint Code E;44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0483-6 180 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2017 2 NDC:71335-0483-7 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2017 3 NDC:71335-0483-4 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2017 4 NDC:71335-0483-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2017 5 NDC:71335-0483-2 15 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2017 6 NDC:71335-0483-5 5 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2017 7 NDC:71335-0483-3 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202039 01/15/2015 Labeler - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0483) , RELABEL(71335-0483)