NDC Code(s) : 49781-103-39
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Leader NicotineNicotine Polacrilex LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49781-103
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE(UNII: 6M3C89ZY6R)
(NICOTINE - UNII:6M3C89ZY6R) 		NICOTINE2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
CALCIUM POLYCARBOPHIL(UNII: 8F049NKY49)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM CARBONATE(UNII: 45P3261C7T)
SUCRALOSE(UNII: 96K6UQ3ZD4)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 10 mm
Flavor MINT Imprint Code L734
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49781-103-393 in 1 CARTON
127 in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203690 11/10/2014

PRINCIPAL DISPLAY PANEL

Compare to Nicorette® mini Lozenge active ingredient

Nicotine Polacrilex Lozenge 2 mg (nicotine)

Stop Smoking Aid

mini Lozenge

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex Lozenge, 4 mg

2 mg

Mint Flavor

Actual Size

QuitTube®

NEW DIRECTIONS FOR USE

Keep Using if You Slip Up and Have a Cigarette

Use Beyond 12 Weeks if Needed to Quit

81 LOZENGES (3 mini QuitTube® containers of 27)

Leader Nicotine Polacrilex Lozenge Image 1Leader Nicotine Polacrilex Lozenge Image 1