87135-001 quit smoking patches

87135-001 quit smoking patches
SPL v1
SPL
SPL Set ID 40b1c2ab-a14d-0884-e063-6294a90a6ecb
Route
topical
Published
Effective Date 2025-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
nicotine (21 mg)
Inactive Ingredients
methacrylic acid - methyl methacrylate copolymer (1:1)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-09

Description

nicotine


Medication Information

Warnings and Precautions

lf you are pregnant or breast-feeding, only usethis medicine on the advice of your health careproviderSmoking can seriously harm your child, Try tostop smoking without using any nicotinereplacement medicine This medicine is believedto be safer than smoking. However, the risks toyour child from this medicine are not fullyknown.

Active Ingredient

nicotine

Indications and Usage

Use reduces withdrawal symptoms, includingnicotine craving, associated with quittingsmoking

Dosage and Administration



Directions

lf you are under 18 years of age,ask a doctor before use

Before using this product, read the enclosedself-help guide for complete directions andother information

Begin using the patch on your quit dayIf you smoke more than 10 cigarettes perday,use the following schedule below

Weeks 1-4

step1 Use one 21 mgpatch / day

Weeks 5-6

step2 Use one 14 mg patch / day

Weeks 7-8

step3 Use one 7 mgpatch / day

lf you smoke 10 or less cigarettes per day,start with Step2 for 6 weeks, then step 3 for2 weeks Apply one new patch every 24 hourson skin that is dry,clean and hairless.Remove backing from patch andimmediately press onto skin, Hold for 10seconds.Wash hands after applying orremoving patch,Save pouch to use for patch disposal.Dispose of the used patches by folding stickyends together and putting in pouch.The used patch should be removed and anew one applied to a different skin site atthe same time each day.if you have vivid dreams, you may removethe patch at bedtime and apply a new one inthe morning.

Do not wear more than one patch at a time.Do not cut patch in half or into smailerpieces.Do not leave patch on for more than 24hours because it may imitate your skin andloses strength after 24 hours.To avoid p¶ssible burns, remove patchbefore undergoing any MRl (magneticresonance imaging)procedures.It is important to complete treatment, if youfeel youneed to use the patch for a longerperiod to keep from smoking, taik to yourhealth care provider.

Description

nicotine

Section 50565-1



Keep out of reach of children and pets

Used patches have enough nicotine to poisonchildren and pets if swallowed, get medicalhelp or conlact a poison control center rightaway. Save pouch to use for patch disposal.Dispose o the used patches by foiding sticky ands together and putung in pouch.

Section 50566-9



When using this product Stop use and ask a doctor if

if you have vivid dreams or other sleep disturbances remove this patch in bedtime

Section 50567-7

Ask a doctor before use if you havee

Heart disease, recent heart attack, or irregualr heartbeat, Nicotine can increase your heart rate.

High blood pressure not controlled withmedication, Nicotine

can increase your blood pressure.

An allergy to adhesive tape or have skinproblems, because you are more likely to get rashes.



Ask a doctor or pharmacist before use if you are:

Using a non-nicotine stop smoking rug taking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted

Section 51727-6

methacrylic acid copolymer

Section 51945-4

Section 55105-1

Stop smoking aid


Structured Label Content

Warnings and Precautions (34071-1)

lf you are pregnant or breast-feeding, only usethis medicine on the advice of your health careproviderSmoking can seriously harm your child, Try tostop smoking without using any nicotinereplacement medicine This medicine is believedto be safer than smoking. However, the risks toyour child from this medicine are not fullyknown.

Active Ingredient (55106-9)

nicotine

Indications and Usage (34067-9)

Use reduces withdrawal symptoms, includingnicotine craving, associated with quittingsmoking

Dosage and Administration (34068-7)



Directions

lf you are under 18 years of age,ask a doctor before use

Before using this product, read the enclosedself-help guide for complete directions andother information

Begin using the patch on your quit dayIf you smoke more than 10 cigarettes perday,use the following schedule below

Weeks 1-4

step1 Use one 21 mgpatch / day

Weeks 5-6

step2 Use one 14 mg patch / day

Weeks 7-8

step3 Use one 7 mgpatch / day

lf you smoke 10 or less cigarettes per day,start with Step2 for 6 weeks, then step 3 for2 weeks Apply one new patch every 24 hourson skin that is dry,clean and hairless.Remove backing from patch andimmediately press onto skin, Hold for 10seconds.Wash hands after applying orremoving patch,Save pouch to use for patch disposal.Dispose of the used patches by folding stickyends together and putting in pouch.The used patch should be removed and anew one applied to a different skin site atthe same time each day.if you have vivid dreams, you may removethe patch at bedtime and apply a new one inthe morning.

Do not wear more than one patch at a time.Do not cut patch in half or into smailerpieces.Do not leave patch on for more than 24hours because it may imitate your skin andloses strength after 24 hours.To avoid p¶ssible burns, remove patchbefore undergoing any MRl (magneticresonance imaging)procedures.It is important to complete treatment, if youfeel youneed to use the patch for a longerperiod to keep from smoking, taik to yourhealth care provider.

Section 50565-1 (50565-1)



Keep out of reach of children and pets

Used patches have enough nicotine to poisonchildren and pets if swallowed, get medicalhelp or conlact a poison control center rightaway. Save pouch to use for patch disposal.Dispose o the used patches by foiding sticky ands together and putung in pouch.

Section 50566-9 (50566-9)



When using this product Stop use and ask a doctor if

if you have vivid dreams or other sleep disturbances remove this patch in bedtime

Section 50567-7 (50567-7)

Ask a doctor before use if you havee

Heart disease, recent heart attack, or irregualr heartbeat, Nicotine can increase your heart rate.

High blood pressure not controlled withmedication, Nicotine

can increase your blood pressure.

An allergy to adhesive tape or have skinproblems, because you are more likely to get rashes.



Ask a doctor or pharmacist before use if you are:

Using a non-nicotine stop smoking rug taking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted

Section 51727-6 (51727-6)

methacrylic acid copolymer

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop smoking aid


Advanced Ingredient Data


Raw Label Data

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