Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 13107-066-05, 13107-067-05 - Packager: Aurolife Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 26, 2015
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
- 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
For 60 mg:
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 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
For 180 mg:
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 - Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel - 60 mg 500's count
NDC 13107-066-05
*Compare to 12 Hour Allegra®
Allergy active ingredient
Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
Allergy
Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat 12 Hour
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
500 Tablets 60 mg each
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Principal Display Panel - 180 mg 500's count
NDC 13107-067-05
*Compare to 24 Hour Allegra®
Allergy active ingredient
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
Allergy
Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat 24 Hour
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
500 Tablets 180 mg each
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13107-066 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, PREGELATINIZED 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 12mm Flavor Imprint Code E;42 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13107-066-05 1 in 1 CARTON 1 500 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 ANDA202039 08/26/2015 FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13107-067 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) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, PREGELATINIZED 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:13107-067-05 1 in 1 CARTON 1 500 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 ANDA202039 11/19/2014 Labeler - Aurolife Pharma, LLC (829084461) Establishment Name Address ID/FEI Business Operations Aurolife Pharma, LLC 829084461 MANUFACTURE(13107-066, 13107-067)