Nicotine Polacrilex Gum Coated Ice Mint 4 Mg Anda204833 - Equate

Nicotine Polacrilex Gum Coated Ice Mint 4 Mg Anda204833 - Equate
SPL v4
SPL
SPL Set ID 0d53243f-f1a7-4a1d-a93e-c0a8f05ed8df
Route
ORAL
Published
Effective Date 2025-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (4 mg)
Inactive Ingredients
Acacia Acesulfame Potassium Carnauba Wax Fd&c Red No. 40 Hydroxypropyl Cellulose, Unspecified Butylated Hydroxytoluene Sodium Bicarbonate Sodium Carbonate Talc Titanium Dioxide Xylitol Sucralose Hypromellose, Unspecified Fd&c Blue No. 2 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Shape: square Color: yellow Size: 14 mm Score: 1
Marketing Status
ANDA Completed Since 2020-04-27 Until 2027-06-30

Description

Nicotine Polacrilex 4 mg (nicotine)

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Nicotine Polacrilex 4 mg (nicotine)

Use
  • 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.

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

  • 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 to 2 hours

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.

Package Label
SKY Nicotine Polacrilex Gum Fruit Flavor
Other Information
  • each piece contains: calcium 115 mg, sodium 11 mg

  • store at 20 - 25ºC (68 - 77ºF)

  • protect from light

Inactive Ingredients

acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C blue #2, FD&C red #40, FD&C yellow #6, gum base, hydroxypropyl cellulose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

Questions Or Comments?

Call 1-877-440-7867

Principal Display Panel

*Compare to the active ingredient of Nicorrette® Gum

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (nicotine)

Stop Smoking Aid

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP

If you smoke your first cigarette MORE THAN  30 MINUTES after waking up, use Nicotine Polacrilex gum, 2 mg

Sugar Free

COATED FRUIT FLAVOR

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivate to quit

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks

3. Use long enough - Use Nicotine Polacrilex Gum for the full 12 weeks

4. Use with a Support Program as directed in the enclosed User's Guide

To remove the gum, tear off single unit

Peel off backing starting at corner with loose edge

Push gum through foil

  • not for sale to those under 18 years of age
  • proof of age required
  • not for sale in vending machines or from any source where proof of age cannot be verified

*Nicorette is a trademark of GlaxoSmithKline Consumer Healthcare L.P.

*This product is not affiliated with GlaxoSmithKline Consumer Healthcare, L.P.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

Distributed By:

McKesson Corporation dba SKY packaging

4971 Southridge Blvd. Suite 101, Memphis, TN 38141

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)

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

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.

Active Ingredient (in Each Chewing Piece)

Nicotine Polacrilex 4 mg (nicotine)

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. 


Structured Label Content

Use
  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Purpose

Stop smoking aid

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.

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

  • 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 to 2 hours

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.

Package Label
SKY Nicotine Polacrilex Gum Fruit Flavor
Other Information (Other information)
  • each piece contains: calcium 115 mg, sodium 11 mg

  • store at 20 - 25ºC (68 - 77ºF)

  • protect from light

Inactive Ingredients (Inactive ingredients)

acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C blue #2, FD&C red #40, FD&C yellow #6, gum base, hydroxypropyl cellulose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

Questions Or Comments? (Questions or comments?)

Call 1-877-440-7867

Principal Display Panel

*Compare to the active ingredient of Nicorrette® Gum

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (nicotine)

Stop Smoking Aid

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP

If you smoke your first cigarette MORE THAN  30 MINUTES after waking up, use Nicotine Polacrilex gum, 2 mg

Sugar Free

COATED FRUIT FLAVOR

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivate to quit

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks

3. Use long enough - Use Nicotine Polacrilex Gum for the full 12 weeks

4. Use with a Support Program as directed in the enclosed User's Guide

To remove the gum, tear off single unit

Peel off backing starting at corner with loose edge

Push gum through foil

  • not for sale to those under 18 years of age
  • proof of age required
  • not for sale in vending machines or from any source where proof of age cannot be verified

*Nicorette is a trademark of GlaxoSmithKline Consumer Healthcare L.P.

*This product is not affiliated with GlaxoSmithKline Consumer Healthcare, L.P.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

Distributed By:

McKesson Corporation dba SKY packaging

4971 Southridge Blvd. Suite 101, Memphis, TN 38141

Stop Use and Ask A Doctor If (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)

Ask A Doctor Before Use If You Have (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

Keep Out of Reach of Children and Pets. (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.

Active Ingredient (in Each Chewing Piece) (Active ingredient (in each chewing piece))

Nicotine Polacrilex 4 mg (nicotine)

Ask A Doctor Or Pharmacist Before Use If You Are (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. 


Advanced Ingredient Data


Raw Label Data

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