Label: PRIVINE- naphazoline hydrochloride suspension/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 31, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per drop)

    Naphazoline HCl, USP 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    for the temporary relief of nasal congestion

    • due to a cold
    • due to hay fever or other upper respiratory allergies
    • helps clear nasal passages; shrinks swollen membranes
    • temporarily restores freer breathing through the nose
  • Warnings

    Do not use this product in children under 12 years of age because it may cause sedation if swallowed.

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    When using this product

    • do not exceed recommended dosage
    • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
    • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to come back or get worse.
    • the use of this container or dropper by more than one person may spread infection

    Stop use and ask a doctor if symptoms persist

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and over: 1 or 2 drops in each nostril not more often than every 6 hours.
    • children under 12 years of age: consult a doctor.
  • Other information

    • store at room temperature 20°–25°C (68°–77°F).
    • Keep carton for full drug facts.
  • Inactive Ingredients

    benzalkonium chloride, dibasic sodium phosphate, disodium edetate, monobasic sodium phosphate, purified water and sodium chloride.

  • Questions

    Call 1-800-344-7239

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    INSIGHT Pharmaceuticals Corp.
    Langhorne, PA 19047-1749

  • PRINCIPAL DISPLAY PANEL - 25 mL Drops Carton

    Fast
    relief
    of
    stuffy
    nose

    Privine®
    nasal drops
    naphazoline HCl, USP
    Nasal Decongestant

    Important: Do not use if seal under bottle cap imprinted
    with "Sealed for your protection" is missing or broken.

    0.83 fl oz (25mL)

    PRINCIPAL DISPLAY PANEL - 25 mL Drops Carton
  • INGREDIENTS AND APPEARANCE
    PRIVINE 
    naphazoline hydrochloride suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-663
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride0.125 mL  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    sodium phosphate, dibasic (UNII: GR686LBA74)  
    edetate disodium (UNII: 7FLD91C86K)  
    sodium phosphate, monobasic (UNII: 3980JIH2SW)  
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorWHITE (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-663-011 in 1 BOX
    125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/16/2009
    Labeler - Insight Pharmaceuticals LLC (176792315)
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