Rugby Nicotine Polacrilex Gum, Mint Flavor: Package Insert and Label Information

RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR- nicotine gum, chewing
REMEDYREPACK INC.

Drug Facts

Active ingredient (in each chewing piece) — 2 mg

Nicotine Polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) — 4 mg

Nicotine Polacrilex 4 mg (nicotine)

Purpose

Stop smoking aid

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.

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 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 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.

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 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 our health care provider.

Other information — 2 mg

  • each piece contains: calcium 115 mg, sodium 8 mg
  • store at 20 — 25ºC (68 — 77ºF)
  • protect from light

Other information — 4 mg

  • each piece contains: calcium 120 mg, sodium 8 mg
  • store at 20 — 25ºC (68 — 77ºF)
  • protect from light

Inactive ingredients — 2 mg

carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc and xylitol.

Inactive ingredients — 4 mg

carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc and xylitol.

Questions or comments?

Call 1-877-440-7867

TO INCREASE YOUR SUCCESS IN QUITTING:

To remove the gum, tear off single unit. Peel off backing starting at corner with loose edge. Push gum through foil.
(click image for full-size original)

TO INCREASE YOUR SUCCESS IN QUITTING:

  1. You must be motivated 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.
  • 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.

Blister packaged for your protection.
Do not use if individual seals are open or torn.

Nicotine Gum 4mg Gum. square, white (off white to tan), Mint, 14mm, no score, no imprint

NDC: 70518-1048-00 30 in 1 BLISTER PACK

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Rugby Nicotine Polacrilex Gum, Mint Flavor

GENERIC: Nicotine Polacrilex

DOSAGE: GUM, CHEWING

ADMINSTRATION: BUCCAL

NDC: 70518-1048-0

COLOR: white

FLAVOR: MINT

SHAPE: SQUARE

SCORE: No score

SIZE: 14 mm

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • NICOTINE 4mg in 1

INACTIVE INGREDIENT(S):

  • CARNAUBA WAX
  • MAGNESIUM OXIDE
  • SODIUM BICARBONATE
  • SODIUM CARBONATE
  • TALC
  • XYLITOL
Remedy_Label
(click image for full-size original)
RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-1048(NDC:0536-1372)
Route of Administration BUCCAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
MAGNESIUM OXIDE
SODIUM BICARBONATE
SODIUM CARBONATE
TALC
XYLITOL
Product Characteristics
Color white (off-white to tan) Score no score
Shape SQUARE Size 14mm
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-1048-0 30 GUM, CHEWING in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076568 08/14/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 06/2020 REMEDYREPACK INC.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.