Privine
FDA Label NDC 63736-663

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Privine (NDC 63736-663). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per drop), purpose, uses, warnings, otc - ask doctor, when using this product, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - Ask Doctor

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

Otc - Stop Use

Stop use and ask a doctor if symptoms persist

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (25 mL Drops Carton)

* Please review the disclaimer below.