85806-001 seno oral film

85806-001 seno oral film
SPL v1
SPL
SPL Set ID 375d248b-8ba4-1ccb-e063-6294a90af2cf
Route
oral
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
nicotine (1.5 mg)
Inactive Ingredients
polyethylene glycol 400 peppermint oil polyglycerol polyricinoleic acid spearmint oil pectin rebaudioside a glycerin xanthan gum

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2025-06-13

Description

Nicotine 1.5%


Medication Information

Warnings and Precautions

Minors under 18 years old are prohibited from using it.

Active Ingredient

Nicotine 1.5%

Indications and Usage

Help smokers alleviate withdrawal symptoms

and increase the success rate ofquitting smoking

Dosage and Administration

Please follow the instructions in the picture

Description

Nicotine 1.5%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9

if you experience symptoms such as nausea, vomiting,diarhea,abdominalpain, diarhea, headache, dizzinessetc,please consult a doctor.

Section 50567-7

Pregnantorlactating women should consutt a medical professional before use, Please keep outofreach ofchildren.lfoverdosed, seekmedical assistance orimmediately contact a poison control center.

Section 50570-1

Pregnantand lactating women, patients with heart disease,hypertension, diabetes, and those allergic to nicotine.

Section 51727-6

Glycerol

Polyethylene glycol 400

Natural pectin

Appropriate amount of essence

Appropriate amount of natural mint essence

Prolulan polysaccharide

polyglycerol fatty acid ester

Moderate amount of sweetener

Section 51945-4

Section 55105-1

Relieve mental fatigue


Structured Label Content

Warnings and Precautions (34071-1)

Minors under 18 years old are prohibited from using it.

Active Ingredient (55106-9)

Nicotine 1.5%

Indications and Usage (34067-9)

Help smokers alleviate withdrawal symptoms

and increase the success rate ofquitting smoking

Dosage and Administration (34068-7)

Please follow the instructions in the picture

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9 (50566-9)

if you experience symptoms such as nausea, vomiting,diarhea,abdominalpain, diarhea, headache, dizzinessetc,please consult a doctor.

Section 50567-7 (50567-7)

Pregnantorlactating women should consutt a medical professional before use, Please keep outofreach ofchildren.lfoverdosed, seekmedical assistance orimmediately contact a poison control center.

Section 50570-1 (50570-1)

Pregnantand lactating women, patients with heart disease,hypertension, diabetes, and those allergic to nicotine.

Section 51727-6 (51727-6)

Glycerol

Polyethylene glycol 400

Natural pectin

Appropriate amount of essence

Appropriate amount of natural mint essence

Prolulan polysaccharide

polyglycerol fatty acid ester

Moderate amount of sweetener

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Relieve mental fatigue


Advanced Ingredient Data


Raw Label Data

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