Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated
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- NDC Code(s): 61919-536-30
- Packager: DirectRX
- This is a repackaged label.
- Source NDC Code(s): 45802-571
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 7, 2015
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- do not use if printed foil under cap is broken or missing
- store at 20°-25°C (68°-77°F)
- protect from excessive moisture
- this product meets the requirements of USP Dissolution Test 3
- Inactive Ingredients
- Package Label
- INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-536(NDC:45802-571) 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 POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color orange (peach) Score no score Shape ROUND Size 12mm Flavor Imprint Code 93;7253 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-536-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/04/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076447 12/03/2015 Labeler - DirectRX (079254320) CloseEstablishment Name Address ID/FEI Business Operations DirectRX 079254320 repack(61919-536)
