Label: NAZAL- naphazoline hydrochloride liquid

  • NDC Code(s): 49873-057-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    nazalcart.jpg Carton

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!