Otc - Active Ingredient
Active ingredients
Naphazoline hydrochloride 0.05%
Nazal Liquid
FDA Label NDC 49873-057
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Nazal (NDC 49873-057). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose Nasal decongestant
Indications & Usage
Uses for the temporary relief of nasal congestion due to the common cold, hay fever, or associated with sinusitis
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
■for more than 3 days
■in children under 12 years of age because it may cause sedation if swallowed
Otc - Ask Doctor
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
Otc - When Using
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
Otc - Stop Use
Stop use and ask a doctor if
■symptoms persist
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep our of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & 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
Other Safety Information
Other information
■container is filled to proper level for best spray action
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, citric acid, dibasic potassium phosphate, fragrance, monobasic potassium phosphate, simethicone, sodium chloride, water
Package Label.Principal Display Panel
nazalPDP.jpg
nazalcart.jpg
Carton (Nazalcart)
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