NICORELIEF nicotine polacrilex lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)

Available from:

Major Pharmaceuticals

INN (International Name):

NICOTINE

Composition:

NICOTINE 2 mg

Prescription type:

OTC DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NICORELIEF- NICOTINE POLACRILEX LOZENGE
MAJOR PHARMACEUTICALS
----------
MAJOR PHARMACEUTICALS NICORELIEF® DRUG FACTS
ACTIVE INGREDIENT (IN EACH LOZENGE)
Nicotine polacrilex, 2 mg (nicotine)
PURPOS E
Stop smoking aid
US ES
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.
DO NOT USE
if you continue to smoke, chew tobacco, use snuff, or use a nicotine
patch or other nicotine
containing products
ASK A DOCTOR BEFORE USE IF YOU HAVE
a sodium-restricted diet
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
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 or
rapid heartbeat
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
if you are under 18 years of age, ask a doctor before use
before using this product, read the enclosed User’s Guide for
complete directions and other
important information
stop smoking completely when you begin using the l