NDC Code(s) : 41167-4320-3, 41167-4320-5, 41167-4320-7
Packager : Chattem, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-4320
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE(UNII: 2S068B75ZU)
(FEXOFENADINE - UNII:E6582LOH6V) 		FEXOFENADINE HYDROCHLORIDE180 mg
PSEUDOEPHEDRINE HYDROCHLORIDE(UNII: 6V9V2RYJ8N)
(PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) 		PSEUDOEPHEDRINE HYDROCHLORIDE240 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIACETIN(UNII: XHX3C3X673)
ACETONE(UNII: 1364PS73AF)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSES(UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POVIDONE(UNII: FZ989GH94E)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color white Score no score
Shape ROUND Size 19 mm
Flavor Imprint Code 308;AV
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41167-4320-31 in 1 CARTON 03/03/2011
15 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:41167-4320-52 in 1 CARTON 03/03/2011
25 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:41167-4320-73 in 1 CARTON 03/03/2011
35 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021704 03/03/2011

LABELER - Chattem, Inc.(003336013)

PRINCIPAL DISPLAY PANEL

NDC 41167-4320-7
NON-DROWSY
Allegra-D®
ALLERGY & CONGESTION
fexofenadine HCl 180 mg/antihistamine
pseudoephedrine HCl 240 mg/nasal decongestant
Extended Release Tablets
15 Tablets

PRINCIPAL DISPLAY PANEL NDC 41167-4320-7 NON-DROWSY Allegra-D® ALLERGY & CONGESTION fexofenadine HCl 180 mg/antihistamine pseudoephedrine HCl 240 mg/nasal decongestant Extended Release Tablets 15 Tablets