87278-001 guhio nicotine patch

87278-001 guhio nicotine patch
SPL v1
SPL
SPL Set ID 45a53cd6-3e3f-697a-e063-6394a90a6c83
Route
transdermal
Published
Effective Date 2025-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
nicotine (21 mg)
Inactive Ingredients
powdered cellulose 2-hydroxyethyl acrylate methacrylic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-11

Description

Nicotine


Medication Information

Warnings and Precautions



Not for non-smokers. Keep away from children/pets. Consult doctor if pregnant/nursing

For external use only.flammable,keep away from heat or flame.

Active Ingredient

Nicotine

Indications and Usage

Helps reducewithdrawal symptoms,such as nicotine cravings,during smoking cessation.

Dosage and Administration



Apply one patch to a clean, dry,and hairless area of skin (e.g.,upper arm or torso)

Replace thepatchevery24hourswithanewone

Rotate application sites to avoid skin irritation

Description

Nicotine

Section 50565-1

Keep away from children/pets. Consult doctor if pregnant/nursing

Section 50566-9

OTC- Stop Use Section.lf you experience severe skin iritation, rregular heartbeat, or: symptoms of nicotine overdose (e.g.,dizziness, nausea, vomiting)

Section 50567-7

When using section. Avoid smoking or using other nicotine-containing products to prevent nicotine overdose

Ask Doctor. Before use if you have heart disease, high blood pressure, or.are taking prescription medication.

Section 50570-1

Not for non-smokers.

Section 51727-6

2-Hydroxyethyl Acrylate, Powdered Cellulose, Methacrylic Acid

Section 51945-4

Section 55105-1

Stop Smoking Aid


Structured Label Content

Warnings and Precautions (34071-1)



Not for non-smokers. Keep away from children/pets. Consult doctor if pregnant/nursing

For external use only.flammable,keep away from heat or flame.

Active Ingredient (55106-9)

Nicotine

Indications and Usage (34067-9)

Helps reducewithdrawal symptoms,such as nicotine cravings,during smoking cessation.

Dosage and Administration (34068-7)



Apply one patch to a clean, dry,and hairless area of skin (e.g.,upper arm or torso)

Replace thepatchevery24hourswithanewone

Rotate application sites to avoid skin irritation

Section 50565-1 (50565-1)

Keep away from children/pets. Consult doctor if pregnant/nursing

Section 50566-9 (50566-9)

OTC- Stop Use Section.lf you experience severe skin iritation, rregular heartbeat, or: symptoms of nicotine overdose (e.g.,dizziness, nausea, vomiting)

Section 50567-7 (50567-7)

When using section. Avoid smoking or using other nicotine-containing products to prevent nicotine overdose

Ask Doctor. Before use if you have heart disease, high blood pressure, or.are taking prescription medication.

Section 50570-1 (50570-1)

Not for non-smokers.

Section 51727-6 (51727-6)

2-Hydroxyethyl Acrylate, Powdered Cellulose, Methacrylic Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop Smoking Aid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)