SPL v2
SPL
SPL Set ID e9da6f39-8620-faca-e053-2995a90a8a57
Route
NASAL
Published
Effective Date 2022-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Xylometazoline (1 mg)
Inactive Ingredients
Cobalt Disodium Edetate Eucalyptus Oil Levomenthol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-09-30

Description

Xylometazoline Hydrochloride


Medication Information

Warnings and Precautions

■ When using this product Stop use and ask a doctor if nervousness, diziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days. fever gets worse or lasts more than 3 days New symtoms occur. keep out of reach of children. In case of overdose, get medical help or contact a poison contral center right away. If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage

Adults and children 7 years and older: Spray into the nose 3 times a day

Dosage and Administration

for nasal use

Description

Xylometazoline Hydrochloride

Section 50565-1

Keep out of reach of children

Section 51727-6

l-menthol, eucalyptus oil, etc

Section 51945-4

Section 55105-1

■ relieve your cold symptoms cold Rhinitis

Section 55106-9

Xylometazoline Hydrochloride


Structured Label Content

Indications and Usage (34067-9)

Adults and children 7 years and older: Spray into the nose 3 times a day

Dosage and Administration (34068-7)

for nasal use

Warnings and Precautions (34071-1)

■ When using this product Stop use and ask a doctor if nervousness, diziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days. fever gets worse or lasts more than 3 days New symtoms occur. keep out of reach of children. In case of overdose, get medical help or contact a poison contral center right away. If pregnant or breast-feeding, ask a health professional before use.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

l-menthol, eucalyptus oil, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ relieve your cold symptoms cold Rhinitis

Section 55106-9 (55106-9)

Xylometazoline Hydrochloride


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)