Nicotine Polacrilex Gum 2 mg and 4 mg Coated Cinnamon - Rugby
Nicotine Polacrilex by
Drug Labeling and Warnings
Nicotine Polacrilex by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
NICOTINE POLACRILEX- nicotine polacrilex gum, chewing
REMEDYREPACK INC.
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Nicotine Polacrilex Gum 2 mg and 4 mg Coated Cinnamon - Rugby
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
- 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
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, 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)
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 (1-800-222-1222) right away.
Directions - 2 mg
- 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
- begin using the gum on your quit day
- if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum
- if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule:
| Weeks 1 to 6 | Weeks 7 to 9 | Weeks 10 to 12 |
|
1 piece every
| 1 piece every
2 to 4 hours | 1 piece every
4 to 8 hours |
- nicotine gum is a medicine and must be used a certain way to get the best results
- chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again until the tingle returns.
- repeat this process until most of the tingle is gone (about 30 minutes)
- do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
- to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
- if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
- do not use more than 24 pieces a day
- it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.
Directions - 4 mg
- 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
- begin using the gum on your quit day
- if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum
- if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule:
| Weeks 1 to 6 | Weeks 7 to 9 | Weeks 10 to 12 |
|
1 piece every
| 1 piece every
2 to 4 hours | 1 piece every
4 to 8 hours |
- nicotine gum is a medicine and must be used a certain way to get the best results
- chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again until the tingle returns.
- repeat this process until most of the tingle is gone (about 30 minutes)
- do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
- to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
- if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
- do not use more than 24 pieces a day
- it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.
Other information - 2 mg
- each piece contains: calcium 115 mg, sodium 11 mg
- store at 20 - 25ºC (68 - 77ºF)
- protect from light
Other information - 4 mg
- each piece contains: calcium 115 mg, sodium 11 mg
- store at 20 - 25ºC (68 - 77ºF)
- protect from light
Inactive ingredients - 2 mg
acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.
Inactive ingredients - 4 mg
acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.
PRINCIPAL DISPLAY PANEL
DRUG: Nicotine Polacrilex
GENERIC: Nicotine Polacrilex
DOSAGE: GUM, CHEWING
ADMINSTRATION: BUCCAL
NDC: 70518-2844-0
COLOR: pink
FLAVOR: CINNAMON
SHAPE: SQUARE
SCORE: No score
SIZE: 14 mm
PACKAGING: 1 in 1 BLISTER PACK
OUTER PACKAGING: 100 in 1 CARTON
ACTIVE INGREDIENT(S):
- NICOTINE 4mg in 1
INACTIVE INGREDIENT(S):
- ACACIA
- ACESULFAME POTASSIUM
- BUTYLATED HYDROXYTOLUENE
- CARNAUBA WAX
- FD&C RED NO. 40
- HYDROXYPROPYL CELLULOSE (90000 WAMW)
- HYPROMELLOSE, UNSPECIFIED
- SODIUM BICARBONATE
- SODIUM CARBONATE
- SUCRALOSE
- TALC
- TITANIUM DIOXIDE
- XYLITOL
| NICOTINE POLACRILEX
nicotine polacrilex gum, chewing |
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| Labeler - REMEDYREPACK INC. (829572556) |
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