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Nazal (Sato Pharmaceutical Co., Ltd.)

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LIQUID 1 BOTTLE in 1 CARTON (49873-057-01) > 30 mL in 1 BOTTLE Label Information

Complete Nazal Information

  • 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
    â– for more than 3 days
    â– in children under 12 years of age because it may cause sedation if swallowed

    Ask a doctor before use if you have
    â– heart disease
    â– high blood pressure
    â– thyroid disease  â– diabetes
    â– difficulty in urination due to enlargement of the prostate gland

    When using this product
    â– do not exceed recommended dosage
    â– if may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
    â– the use of this container by more than one person may spread infection
    â– use only as directed
    â– frequent or prolonged use may cause nasal congestion to recur or worsen

    Stop use and ask a doctor if
    â– 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  
    â– 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

    nazalPDP.jpgPDP


  • PRINCIPAL DISPLAY PANEL

    nazalcart.jpgCarton


  • 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
    1 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part341 06/11/1990
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical Co., Ltd. 715699133 manufacture, label, pack