Neilmed Sinufrin Quick Relief Decongestant

Neilmed Sinufrin Quick Relief Decongestant
SPL v2
SPL
SPL Set ID 0c36a34e-462d-713c-e063-6294a90a1776
Route
NASAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.4 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Chloride Edetate Disodium Sodium Bicarbonate Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-11

Description

Oxymetazoline hydrochloride 0.04%

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Oxymetazoline hydrochloride 0.04%

Uses:
  • Temporarily relieves nasal congestion due to:
  • Common cold
  • Hay fever
  • Upper respiratory allergies
  • Temporarily relieves sinus congestion and pressure
  • Shrinks swollen nasal membranes so you can breathe more freely
Section 60561-8

Other Information

  • Store between 68° F (20° C) and 86° F (30° C)
  • Retain carton for future reference on full labeling
Warnings

Ask a doctor before use if you have

  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • Trouble urinating due to an enlarged prostate gland
Directions
  • Adults and children 6 to under 12 years of age (with adult supervision): 3 or 4 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age: ask a doctor To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.
Drug Facts

Oxymetazoline hydrochloride 0.04%

Inactive Ingredients

Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water.

Principal Display Panel

When Using This Product

  • Do not use more than directed
  • Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • Temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • Use of this container by more than one person may spread infection.

Structured Label Content

Uses:
  • Temporarily relieves nasal congestion due to:
  • Common cold
  • Hay fever
  • Upper respiratory allergies
  • Temporarily relieves sinus congestion and pressure
  • Shrinks swollen nasal membranes so you can breathe more freely
Section 60561-8 (60561-8)

Other Information

  • Store between 68° F (20° C) and 86° F (30° C)
  • Retain carton for future reference on full labeling
Purpose

Nasal Decongestant

Warnings

Ask a doctor before use if you have

  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • Trouble urinating due to an enlarged prostate gland
Directions
  • Adults and children 6 to under 12 years of age (with adult supervision): 3 or 4 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age: ask a doctor To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.
Drug Facts

Oxymetazoline hydrochloride 0.04%

Inactive Ingredients

Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water.

Principal Display Panel

When Using This Product (When using this product)

  • Do not use more than directed
  • Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • Temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • Use of this container by more than one person may spread infection.

Advanced Ingredient Data


Raw Label Data

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