NAZAL- naphazoline hydrochloride liquid

Nazal by

Drug Labeling and Warnings

Nazal by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Naphazoline hydrochloride 0.05%

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

Do not use
■for more than 3 days
■in children under 12 years of age because it may cause sedation if swallowed

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

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

Stop use and ask a doctor if
■symptoms persist

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAZAL 
naphazoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-057
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Naphazoline hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV)	Naphazoline hydrochloride	50 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride (UNII: F5UM2KM3W7)
citric acid monohydrate (UNII: 2968PHW8QP)
potassium phosphate, dibasic (UNII: CI71S98N1Z)
potassium phosphate, monobasic (UNII: 4J9FJ0HL51)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
sodium chloride (UNII: 451W47IQ8X)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-057-01	1 in 1 CARTON	06/11/1990
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/11/1990

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-057) , label(49873-057) , pack(49873-057)