NICOTINE MINI- nicotine polacrilex lozenge

United States - English - NLM (National Library of Medicine)

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Active ingredient:
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)
Available from:
Rugby Laboratories, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stop smoking aid - reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Authorization status:
Abbreviated New Drug Application
Authorization number:
0536-1239-81

NICOTINE MINI- nicotine polacrilex lozenge

Rugby Laboratories, Inc.

----------

Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex 2 mg

Purpos e

Stop smoking aid

Us e

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding,

only use this medicine on the advice of your health care provider. Smoking can seriously harm your

child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed

to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.

high blood pressure not controlled with medication. Nicotine can increase your blood pressure.

stomach ulcer or diabetes

history of seizures

Ask a doctor or pharmacist before use if you are

using a non-nicotine stop smoking drug

taking prescription medicine for depression or asthma. Your prescription dose may need to be

adjusted.

Stop use and ask a doctor if

mouth problems occur

persistent indigestion or severe sore throat occurs

irregular heartbeat or palpitations occur

you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and

rapid heartbeat

you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the

lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a

Poison Control Center right away (1-800-222-1222).

Directions (2 mg lozenge)

if you are under 18 years of age, ask a doctor before use. No studies have been done to show

if this product will work for you.

before using this product, read the enclosed User’s Guide for complete directions and other

important information

begin using the lozenge on your quit day

if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge

if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine

lozenge according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 lozenge every 1 to 2 hours

1 lozenge every 2 to 4 hours

1 lozenge every 4 to 8 hours

nicotine lozenge is a medicine and must be used a certain way to get the best results

place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing.

Do not chew or swallow lozenge.

you may feel a warm or tingling sensation

occasionally move the lozenge from one side of your mouth to the other until completely dissolved

do not eat or drink 15 minutes before using or while the lozenge is in your mouth

to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks

do not use more than one lozenge at a time or continuously use one lozenge after another since this

may cause you hiccups, heartburn, nausea or other side effects

do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.

It is important to complete treatment. If you feel you need to use the lozenge for a longer period to

keep from smoking, talk to your health care provider.

Other information

Phenylketonurics: Contains Phenylalanine 2.8 mg per lozenge

store at 20-25ºC (68-77ºF)

keep vial tightly closed and protect from light

Inactive ingredients

aspartame, calcium polycarbophil, flavor, maltodextrin, mannitol, sodium alginate, sodium bicarbonate,

sodium stearyl fumarate, talc, xanthan gum

Questions or comments?

Call 1-800-645-2158

Principal Display Panel (2 mg lozenge)

Compare to the active ingredient in Nicorette® mini Lozenge*

NICOTINE

mini Lozenge

Nicotine polacrilex 2 mg

Stop Smoking Aid

Mint Flavor

2 mg

User's Guide Included

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 4 mg

Lozenge

LOZENGES, 2 mg Each (Vials)

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough - Use at least 9 Nicotine mini lozenges per day during the first six weeks.

3. Use Long Enough - Use Nicotine mini lozenges for the full 12 weeks.

4. Use With a Support Program as directed in the enclosed User's Guide.

not for sale to those under 18 years of age

proof of age required

not for sale in vending machines or from any source where proof of age cannot be verified

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P.,

distributor of Nicorette® mini Lozenge.

See inside for more detail or visit www.nixthehabit.com

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN

OR MISSING.

RETAIN OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT

INFORMATION

Distributed by:

RUGBY® LABORATORIES

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Package Label (2 mg lozenge)

RUGBY Nicotine Mini Lozeng e

NICOTINE MINI

nicotine polacrilex lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 536 -1239

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NICO TINE (UNII: 6 M3C8 9 ZY6 R) (NICOTINE - UNII:6 M3C8 9 ZY6 R)

NICOTINE

2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

CALCIUM PO LYCARBO PHIL (UNII: 8 F0 49 NKY49 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

MANNITO L (UNII: 3OWL53L36 A)

SO DIUM ALGINATE (UNII: C26 9 C4G2ZQ)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

TALC (UNII: 7SEV7J4R1U)

XANTHAN GUM (UNII: TTV12P4NEE)

Rugby Laboratories, Inc.

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

10 mm

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 536 -1239 -

3 in 1 BOX

0 7/31/20 19

1

27 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 78 6 8

0 7/31/20 19

Labeler -

Rugby Laboratories, Inc. (079246066)

Revised: 8/2019

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