NDC Code(s) : 37205-203-71, 37205-203-46
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Leader NicotineNicotine GUM, CHEWING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37205-203
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
CALCIUM CARBONATE(UNII: H0G9379FGK)
CARNAUBA WAX(UNII: R12CBM0EIZ)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM CARBONATE(UNII: 45P3261C7T)
SORBITOL(UNII: 506T60A25R)
TALC(UNII: 7SEV7J4R1U)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
POLACRILIN(UNII: RCZ785HI7S)
Product Characteristics
Color WHITE (off) Score no score
Shape RECTANGLE Size 16 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37205-203-7150 in 1 CARTON
11 in 1 BLISTER PACK
2NDC:37205-203-46170 in 1 CARTON
21 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076775 05/25/2005

PRINCIPAL DISPLAY PANEL

Compare to Nicorette® Gum active ingredient

Nicotine Polacrilex Gum 2 mg (nicotine)

Stop Smoking Aid

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 Gum, 4 mg

Original Flavor

2 mg

Actual Size

NEW DIRECTIONS FOR USE

Keep Using if You Slip Up and Have a Cigarette

Use Beyond 12 Weeks if Needed to Quit

170 PIECES, 2 mg EACH

Leader Nicotine Polacrilex Gum Image 1Leader Nicotine Polacrilex Gum Image 1