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Nazal

Sato Pharmaceutical Co., Ltd.

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients  
Naphazoline hydrochloride 0.05%

Purpose

Purpose    Nasal decongestant

Uses

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

nazalPDP.jpgNazal

nazalcart.jpgNazal

Nazal

Naphazoline hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49873-057
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naphazoline hydrochloride Naphazoline 50 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
CITRIC ACID MONOHYDRATE
potassium phosphate, dibasic
POTASSIUM PHOSPHATE, MONOBASIC
DIMETHICONE
SILICON DIOXIDE
SODIUM CHLORIDE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:49873-057-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1990-06-11


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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