Rugby Nicotine Polacrilex Gum, Mint Flavor

Manufacturer
A-S Medication Solutions
Effective date
2025-09-23
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:14:27

Label at a glance#

ProductRugby Nicotine Polacrilex Gum, Mint Flavor
Active ingredientNICOTINE
Label structure18 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 (equal to 2 mg nicotine)

Active ingredient (in each chewing piece) - 4 mg

OTC - ACTIVE INGREDIENT SECTION

Nicotine Polacrilex (equal to 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 (1-800-222-1222) 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, xylitol.

Inactive ingredients - 4 mg

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-3560

NDC: 50090-3560-0 10 GUM, CHEWING in a BLISTER PACK / 11 in a CARTON

Nicotine Polacrilex

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN16
314119nicotine 2 MG Chewing GumSCD16
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY16

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3560-0Rugby Nicotine Polacrilex Gum, Mint Flavor11 in 1 CARTONGUM, CHEWING1116
50090-3560-0Rugby Nicotine Polacrilex Gum, Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3560-0EA - Each50090-3560829ebbcc-7edf-4460-b1c6-b5e3314ba7e312021-11-09
0536-1362-06EA - Each0536-1362f6aa756d-b9bf-4a97-9457-55210ab98cf212013-02-13
0536-1362-23EA - Each0536-1362b9e570a5-cd24-4c9b-bf29-fd400f0f6ba412013-02-13
0536-1362-34EA - Each0536-1362eebac00b-7910-4f44-9425-2020c54654e712013-02-13

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
50090-356050090-3560-0
0536-1362

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
A076569-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG 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 22:38:342026-08A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-2984e616aacf4f…
2026-08-18 06:07:402026-07A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-293f01610625f2…
2019-09-15 20:21 UTC2019-09A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076569-001NICOTINE POLACRILEXEQ 2MG 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): 0536-1362
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXA-S Medication Solutions7b70162e-0087-466f-9b8b-8289b6e90e392025-09-23WarningsExact identifier
ndc (package): 50090-3560-0
ndc (product): 50090-3560
ndc11 (package): 50090356000
spl id: 8daba42e-328d-4a3a-a233-0b457e7aa7f7
spl set id: 7b70162e-0087-466f-9b8b-8289b6e90e39

Reported adverse events (FAERS/openFDA)#

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