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Privine

Insight Pharmaceuticals LLC

Privine nasal drops


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (per drop)

Naphazoline HCl, USP 0.05%

Purpose

Nasal decongestant

Privine 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

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.

Privine 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

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)

Privine

Privine

Naphazoline Hydrochloride SUSPENSION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-663
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naphazoline hydrochloride Naphazoline 0.125 mL

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
SODIUM PHOSPHATE, DIBASIC
EDETATE DISODIUM
sodium phosphate, monobasic
water
SODIUM CHLORIDE

Product Characteristics

Color
WHITE (clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 BOTTLE
2 NDC:63736-663-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-07-16


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Be sure to consult your doctor before taking any medication!
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