Nazal

Drug Facts

Composition & Product

Active Ingredients

Naphazoline (50 mg)

Inactive Ingredients

Citric Acid Monohydrate Potassium Phosphate, Dibasic Potassium Phosphate, Monobasic Dimethicone Silicon Dioxide Sodium Chloride Water Benzalkonium Chloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 1990-06-11

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses for the temporary relief of nasal congestion due to the common cold, hay fever, or associated with sinusitis

Dosage and Administration

Directions

Adults and children 12 years of age and older - 1 or 2 sprays in each nostril not more often than every 6 hours

Children under 12 years of age - do not give unless directed by a doctor

Description

Active ingredients Naphazoline hydrochloride 0.05%

Section 50565-1

Keep our of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

■symptoms persist

Section 50567-7

When using this product

■do not exceed recommended dosage

■if may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge

■the use of this container by more than one person may spread infection

■use only as directed

■frequent or prolonged use may cause nasal congestion to recur or worsen

Section 50569-3

Ask a doctor before use if you have

■heart disease

■high blood pressure

■thyroid disease ■diabetes

■difficulty in urination due to enlargement of the prostate gland

Section 50570-1

Do not use

■for more than 3 days

■in children under 12 years of age because it may cause sedation if swallowed

Section 51727-6

Inactive ingredients

benzalkonium chloride, citric acid, dibasic potassium phosphate, fragrance, monobasic potassium phosphate, simethicone, sodium chloride, water

Section 51945-4

nazalcart.jpg

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose Nasal decongestant

Section 55106-9

Active ingredients

Naphazoline hydrochloride 0.05%

Section 60561-8

Other information

■container is filled to proper level for best spray action

Structured Label Content

Indications and Usage (34067-9)

Uses for the temporary relief of nasal congestion due to the common cold, hay fever, or associated with sinusitis

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and older - 1 or 2 sprays in each nostril not more often than every 6 hours

Children under 12 years of age - do not give unless directed by a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep our of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■symptoms persist

Section 50567-7 (50567-7)

When using this product

■do not exceed recommended dosage

■if may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge

■the use of this container by more than one person may spread infection

■use only as directed

■frequent or prolonged use may cause nasal congestion to recur or worsen

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■heart disease

■high blood pressure

■thyroid disease ■diabetes

■difficulty in urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

Do not use

■for more than 3 days

■in children under 12 years of age because it may cause sedation if swallowed

Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, citric acid, dibasic potassium phosphate, fragrance, monobasic potassium phosphate, simethicone, sodium chloride, water

Section 51945-4 (51945-4)

nazalcart.jpg

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients

Naphazoline hydrochloride 0.05%

Section 60561-8 (60561-8)

Other information

■container is filled to proper level for best spray action

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM PHOSPHATE, DIBASIC", "unii": "CI71S98N1Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM PHOSPHATE, MONOBASIC", "unii": "4J9FJ0HL51", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NAPHAZOLINE", "unii": "H231GF11BV", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses for the temporary relief of nasal congestion due to the common cold, hay fever, or associated with sinusitis", "34068-7": "Directions Adults and children 12 years of age and older - 1 or 2 sprays in each nostril not more often than every 6 hours Children under 12 years of age - do not give unless directed by a doctor", "34071-1": "Warnings For external use only", "50565-1": "Keep our of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if ■symptoms persist", "50567-7": "When using this product ■do not exceed recommended dosage ■if may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge ■the use of this container by more than one person may spread infection ■use only as directed ■frequent or prolonged use may cause nasal congestion to recur or worsen", "50569-3": "Ask a doctor before use if you have ■heart disease ■high blood pressure ■thyroid disease ■diabetes ■difficulty in urination due to enlargement of the prostate gland", "50570-1": "Do not use ■for more than 3 days ■in children under 12 years of age because it may cause sedation if swallowed", "51727-6": "Inactive ingredients benzalkonium chloride, citric acid, dibasic potassium phosphate, fragrance, monobasic potassium phosphate, simethicone, sodium chloride, water", "51945-4": "nazalcart.jpg", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Purpose Nasal decongestant", "55106-9": "Active ingredients Naphazoline hydrochloride 0.05%", "60561-8": "Other information ■container is filled to proper level for best spray action"}