Sielkin Quit Smoking Nicotine Patches 21mg

Sielkin Quit Smoking Nicotine Patches 21mg
SPL v2
SPL
SPL Set ID 29b6287b-3ce3-e446-e063-6294a90a163b
Route
TRANSDERMAL
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg)
Inactive Ingredients
Alcohol Borneol Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Acrylic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2026-01-01

Description

​Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Dosage and Administration

Directions

■if you are under 18 years of age, ask a doctor before use.

■Before use, carefuly read the insert for complete instructions.

■lf you smoke more than 10 cigarettes per day, follow this 10-week schedule:

Step 1 Step 2 Step 3
Cigarettes per Day Week 1(Key Adjustment Phase) Weeks 2-6 Weeks 7-8 Weeks 9-10
10-20 cigarettes two 21mg patch/day one 21mg patch/day one 14mg patch/day one 7 mg patch/day
20+ cigarettes three 21mg patch/day two 21mg patch/day one 14mg patch/day one 7 mg patch/day

■lf you smoke 10 or fewer cigarettes per day, skip STEP 1(21mg). Start with STEP 2(14mg) for 6 weeks-using two14mg patches per day for the first week, then one 14mg patch per day for weeks 2 to 6. Then move to STEP 3(7mg) for 2weeks, and stop.

Description

​Drug Facts

Section 50565-1

Keep out of reach of children and pets. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center(1-800-222-1222)

Section 50567-7

When using this product

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

Section 50568-5

Ask a doctor or pharmacist before use if you are■using a non-nicotine stop smoking drug■pregnant or breast-feeding

Section 50569-3

Ask a doctor before use if you have

■heart disease ■high blood pressure ■skin allergies ■diabetes ■history of seizures

Section 51727-6

Inactive ingredients camphor, ethanol, acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Section 51945-4

​Drug Facts

Section 55105-1

Stop smoking aid

Section 55106-9

Active ingredients (in each patch)

Nicotine 21mg delivered over 24 hours

Section 60561-8

Other information Store at 20-25℃ (68-77°F)


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

■if you are under 18 years of age, ask a doctor before use.

■Before use, carefuly read the insert for complete instructions.

■lf you smoke more than 10 cigarettes per day, follow this 10-week schedule:

Step 1 Step 2 Step 3
Cigarettes per Day Week 1(Key Adjustment Phase) Weeks 2-6 Weeks 7-8 Weeks 9-10
10-20 cigarettes two 21mg patch/day one 21mg patch/day one 14mg patch/day one 7 mg patch/day
20+ cigarettes three 21mg patch/day two 21mg patch/day one 14mg patch/day one 7 mg patch/day

■lf you smoke 10 or fewer cigarettes per day, skip STEP 1(21mg). Start with STEP 2(14mg) for 6 weeks-using two14mg patches per day for the first week, then one 14mg patch per day for weeks 2 to 6. Then move to STEP 3(7mg) for 2weeks, and stop.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children and pets. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center(1-800-222-1222)

Section 50567-7 (50567-7)

When using this product

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are■using a non-nicotine stop smoking drug■pregnant or breast-feeding

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■heart disease ■high blood pressure ■skin allergies ■diabetes ■history of seizures

Section 51727-6 (51727-6)

Inactive ingredients camphor, ethanol, acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Section 51945-4 (51945-4)

​Drug Facts

Section 55105-1 (55105-1)

Stop smoking aid

Section 55106-9 (55106-9)

Active ingredients (in each patch)

Nicotine 21mg delivered over 24 hours

Section 60561-8 (60561-8)

Other information Store at 20-25℃ (68-77°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)