NAZAL- naphazoline hydrochloride liquid 
Sato Pharmaceutical Co., Ltd.

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Nazal

Active ingredients  
Naphazoline hydrochloride 0.05%

Purpose    Nasal decongestant

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

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.


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 information  
■container is filled to proper level for best spray action

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

nazalcart.jpg Carton

NAZAL 
naphazoline hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-057
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE50 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-057-011 in 1 CARTON06/11/1990
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/11/1990
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-057) , label(49873-057) , pack(49873-057)

Revised: 12/2023
Document Id: 0bde79a3-26b2-e0d2-e063-6294a90ac663
Set id: 4d4043f8-5ed3-4027-beb6-687db1308202
Version: 7
Effective Time: 20231206
 
Sato Pharmaceutical Co., Ltd.