Label: FEXOFENADINE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 55648-744-08, 55648-744-09, 55648-982-08, 55648-982-09, view more55648-987-05, 55648-987-09, 55648-987-10, 55648-987-11, 55648-987-12, 55648-987-13, 55648-987-14 - Packager: Wockhardt Limited
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 8, 2012
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- 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)
- Keep out of reach of children
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Directions
adults and children 12 years of age and over
take two 30 mg tablets with water every 12 hours;
do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age
take one 30 mg tablet with water every 12 hours;
do not take more than 2 tablets in 24 hours
children under 6 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 tablets in 24 hours
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
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 hours
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?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FEXOFENADINE
fexofenadine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55648-744 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND (round) Size 7mm Flavor Imprint Code W;30 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55648-744-09 1 in 1 CARTON 1 NDC:55648-744-08 6 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079112 02/08/2012 FEXOFENADINE
fexofenadine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55648-982 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape CAPSULE (Capsule) Size 11mm Flavor Imprint Code W;982 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55648-982-09 2 in 1 CARTON 1 NDC:55648-982-08 6 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079112 02/08/2012 FEXOFENADINE
fexofenadine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55648-987 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape CAPSULE (Capsule) Size 17mm Flavor Imprint Code W;987 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55648-987-12 1 in 1 CARTON 1 30 in 1 BOTTLE 2 NDC:55648-987-13 1 in 1 CARTON 2 45 in 1 BOTTLE 3 NDC:55648-987-14 2 in 1 CARTON 3 45 in 1 BOTTLE 4 NDC:55648-987-10 1 in 1 CARTON 4 NDC:55648-987-09 5 in 1 BLISTER PACK 5 NDC:55648-987-11 3 in 1 CARTON 5 NDC:55648-987-09 5 in 1 BLISTER PACK 6 NDC:55648-987-05 2000 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079112 02/08/2012 Labeler - Wockhardt Limited (650069115) Registrant - Wockhardt Limited (650069115) Establishment Name Address ID/FEI Business Operations Wockhardt Limited 676257570 Manufacture