Rugby Nicotine Polacrilex Gum, Mint Flavor

Manufacturer
REMEDYREPACK INC.
Effective date
2020-06-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:28:09

Label at a glance#

ProductRugby Nicotine Polacrilex Gum, Mint Flavor
Active ingredientNICOTINE
Label structure19 sections

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient (in each chewing piece) - 2 mg

OTC - ACTIVE INGREDIENT SECTION

Nicotine Polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) - 4 mg

OTC - ACTIVE INGREDIENT SECTION

Nicotine Polacrilex 4 mg (nicotine)

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Other information - 4 mg

SPL UNCLASSIFIED SECTION

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

Inactive ingredients - 2 mg

INACTIVE INGREDIENT SECTION

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

Inactive ingredients - 4 mg

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-440-7867

TO INCREASE YOUR SUCCESS IN QUITTING:

SPL UNCLASSIFIED SECTION

To remove the gum, tear off single unit. Peel off backing starting at corner with loose edge. Push gum through foil.
To remove the gum, tear off single unit. Peel off backing starting at corner with loose edge. Push gum through foil.

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.

HOW SUPPLIED SECTION

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

PACKAGE LABEL.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_LabelRemedy_Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1372-06EA - Each0536-13727b16c151-e789-407c-a238-3a4e3827512712013-02-13
0536-1372-23EA - Each0536-1372c2f34e82-8f3b-4995-8428-5d7a036adc2912013-02-13
0536-1372-34EA - Each0536-1372a62c73e9-dad0-4391-9d33-dce7552fbb1012013-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-104870518-1048-0
0536-1372

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076568-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-2984e616aacf4f…
2026-08-18 06:07:402026-07A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-293f01610625f2…
2019-09-15 20:21 UTC2019-09A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076568-002NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-07-29f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXRugby Laboratories0f5af06c-ab1c-48d0-a39f-4d1d7e78ff252026-07-10WarningsExact identifier
ndc (product): 0536-1372
c10e37f8-7bf8-6add-e053-2995a90adbceb0e9fd1b-bba7-4b3e-9fc3-1e2a19cde78f2021-04-28WarningsExact identifier
spl set id: b0e9fd1b-bba7-4b3e-9fc3-1e2a19cde78f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.