Topco Associates LLC. Nicotine Polacrilex Gum USP 4 mg (Nicotine) Drug Facts

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Topco Associates LLC

DCI (Dénomination commune internationale):

NICOTINE

Composition:

NICOTINE 4 mg

Mode d'administration:

ORAL

Type d'ordonnance:

OTC DRUG

indications thérapeutiques:

Stop smoking aid

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TOPCARE NICOTINE STOP SMOKING AID- NICOTINE POLACRILEX GUM, CHEWING
TOPCO ASSOCIATES LLC
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TOPCO ASSOCIATES LLC. NICOTINE POLACRILEX GUM USP 4 MG (NICOTINE) DRUG
FACTS
ACTIVE INGREDIENT (IN EACH CHEWING PIECE)
Nicotine polacrilex (equal to 4 mg nicotine)
PURPOSE
Stop smoking aid
USE
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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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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
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.
mouth, teeth or jaw problems occur
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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).
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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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
b