BERKLEY AND JENSEN NICOTINE- nicotine polacrilex gum, chewing

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BJWC

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

BERKLEY AND JENSEN NICOTINE- NICOTINE POLACRILEX GUM, CHEWING
BJWC
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BJWC NICOTINE GUM DRUG FACTS
ACTIVE INGREDIENT (IN EACH CHEWING PIECE)
Nicotine polacrilex (equal to 4 mg nicotine)
PURPOS E
Stop smoking aid
US E
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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
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
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STOP USE AND ASK A DOCTOR IF
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KEEP OUT OF REACH OF CHILDREN AND PETS.
Pieces of nicotine gum may have enough nicotine to make children and
pets sick. Wrap used pieces of
gum 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).
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 blood pressure.
stomach ulcer or diabetes
using a non-nicotine stop smoking drug
taking prescription medicine for depression or asthma. Your
prescription dose may need to be
adjusted.
mouth, teeth or jaw problems occur
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)
DIRECTIONS
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Weeks 1 to 6
Weeks 7 to 9
Weeks 10 to 12
1 piece every
1 to 2 hours
1 piece every
2 to 4 hours
1 piece every
4 to 8 hours
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OTHER INFORMATION
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INACTIVE INGREDIENTS
acesulfame potassium, calcium carbonate, carnauba wax