NDC Code(s) : 60432-539-16
Packager : Morton Grove Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexchlorpheniramine MaleateDexchlorpheniramine Maleate SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-539
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dexchlorpheniramine Maleate(UNII: B10YD955QW)
(Dexchlorpheniramine - UNII:3Q9Q0B929N) 		Dexchlorpheniramine Maleate2 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
GLYCERIN(UNII: PDC6A3C0OX)
Water(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FD&C RED NO. 40(UNII: WZB9127XOA)
CAPTAN(UNII: EOL5G26Q9F)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
Product Characteristics
Color RED, ORANGE Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60432-539-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088251 03/23/1984

PRINCIPAL DISPLAY PANEL

MGP

NDC 60432-539-16

DEXCHLORPHENIRAMINE
MALEATE ORAL
SOLUTION, USP

2 mg/5 mL

(Contains alcohol
not more than 7.0%)

DO NOT USE IF INNER FOIL SEAL PRINTED "SEALED
FOR YOUR PROTECTION" IS BROKEN OR MISSING.

BULK CONTAINER —
NOT FOR HOUSEHOLD USE

Rx Only

NET: 1 Pint (473 mL)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label