Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, 3/4 Fl Oz (22 Ml)

Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, 3/4 Fl Oz (22 Ml)
SPL v2
SPL
SPL Set ID a63508ff-5161-4f69-bd39-9e0dd5b736de
Route
NASAL
Published
Effective Date 2011-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 mg)
Inactive Ingredients
Edetate Disodium Eucalyptol Glycine Polyethylene Glycol Polysorbate 80 Propylene Glycol Sodium Chloride Sodium Hydroxide Water Benzalkonium Chloride Menthol Camphor (natural)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-09-24

Description

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Oxymetazoline hydrochloride 0.05%

Uses
  • Temporarily relieves nasal congestion due to:

                                   ■ a cold ■ hay fever ■ upper respiratory allergies

  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes
Section 42229-5

Stop use and ask a doctor if symptoms persist.

Warnings

Ask a doctor before use if you have

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes

■ trouble urinating due to an enlarged prostate gland

Directions
  • adults and children 6 to under 12 years of age (with adult supervision):

2 or 3 sprays in each nostril not more 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.

Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • Store between 20º - 25ºC (68º - 77ºF)
  • retain carton for future reference on full labeling
Inactive Ingredients

benzalkonium chloride solution, camphor, edetate disodium, eucalyptol, glycin, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide.

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
Container and Carton Labels

NDC 65841-711-07

Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, ¾ FL OZ (22 mL)

Rx only

Zydus

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses (USES)
  • Temporarily relieves nasal congestion due to:

                                   ■ a cold ■ hay fever ■ upper respiratory allergies

  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes
Section 42229-5 (42229-5)

Stop use and ask a doctor if symptoms persist.

Purpose (PURPOSE)

Nasal decongestant

Warnings (WARNINGS)

Ask a doctor before use if you have

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes

■ trouble urinating due to an enlarged prostate gland

Directions
  • adults and children 6 to under 12 years of age (with adult supervision):

2 or 3 sprays in each nostril not more 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.

Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

Active Ingredient (ACTIVE INGREDIENT)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • Store between 20º - 25ºC (68º - 77ºF)
  • retain carton for future reference on full labeling
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride solution, camphor, edetate disodium, eucalyptol, glycin, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide.

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
Container and Carton Labels

NDC 65841-711-07

Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, ¾ FL OZ (22 mL)

Rx only

Zydus

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.


Advanced Ingredient Data


Raw Label Data

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