NICOTINE- nicotine polacrilex lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

CVS Pharmacy

INN (International Name):

NICOTINE

Composition:

NICOTINE 4 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Stop smoking aid

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NICOTINE- NICOTINE POLACRILEX LOZENGE
CVS PHARMACY
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CVS PHARMACY, INC. NICOTINE LOZENGE DRUG FACTS
ACTIVE INGREDIENT (IN EACH LOZENGE)
Nicotine polacrilex, 4 mg (nicotine)
PURPOSE
Stop smoking aid
USE
•
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
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
STOP USE AND ASK A DOCTOR IF
reduces withdrawal symptoms, including nicotine craving, associated
with quitting
smoking
•
•
•
•
•
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
history of seizures
•
•
using a non-nicotine stop smoking drug
taking prescription medicine for depression or asthma. Your
prescription dose
may need to be adjusted.
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
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
•
•
•
•
•
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
you have symptoms of an allergic reaction (such as difficulty
breathing or
rash)
•
•
•
•
•
IF YOU ARE UNDER 18 YEARS OF AGE, ASK A DOCTOR BEFORE USE.