SPL v1
SPL
SPL Set ID 313b08e2-d764-96da-e063-6294a90ab705
Route
TRANSDERMAL
Published
Effective Date 2025-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (42 mg)

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-18
Description

Nicotine 42mg delivered over 24 hours.......................................................Stop Smoking aid Nicotine 21mg delivered over 24 hours.......................................................Stop Smoking aid

Medication Information

Warnings and Precautions

keep out of reach of children section.

Indications and Usage

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

Dosage and Administration

Nicotine 42mg delivered over 24 hours.......................................................Stop Smoking aid

Nicotine 21mg delivered over 24 hours.......................................................Stop Smoking aid

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

Description

Nicotine 42mg delivered over 24 hours.......................................................Stop Smoking aid Nicotine 21mg delivered over 24 hours.......................................................Stop Smoking aid

Section 50565-1

keep out of reach of children section

Section 51727-6

Nicotine 42mg

Section 51945-4

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

Section 55105-1

·apply one new patch every 24 hours on skin that is dry, clean and hairless

·remove backing from patch and immediately press onto skin. Hold for 10 seconds.

·wash hands after applying or removing patch. Save pouch to use for patch disposal.

·the used patch should be removed and a new one applied to a different skin site at the same time each day.

·Dispose of the patches carefully after you have removed ensuring they are out of the reach of children and pets.

Section 55106-9

Nicotine 42mg delivered over 24 hours.......................................................Stop Smoking aid

Nicotine 21mg delivered over 24 hours.......................................................Stop Smoking aid

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Nicotine 42mg delivered over 24 hours.......................................................Stop Smoking aid

Nicotine 21mg delivered over 24 hours.......................................................Stop Smoking aid

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

Warnings and Precautions (34071-1)

keep out of reach of children section.

Section 50565-1 (50565-1)

keep out of reach of children section

Section 51727-6 (51727-6)

Nicotine 42mg

Section 51945-4 (51945-4)

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

Section 55105-1 (55105-1)

·apply one new patch every 24 hours on skin that is dry, clean and hairless

·remove backing from patch and immediately press onto skin. Hold for 10 seconds.

·wash hands after applying or removing patch. Save pouch to use for patch disposal.

·the used patch should be removed and a new one applied to a different skin site at the same time each day.

·Dispose of the patches carefully after you have removed ensuring they are out of the reach of children and pets.

Section 55106-9 (55106-9)

Nicotine 42mg delivered over 24 hours.......................................................Stop Smoking aid

Nicotine 21mg delivered over 24 hours.......................................................Stop Smoking aid

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:47.559483 · Updated: 2026-03-14T23:08:06.304944