SPL v2
SPL
SPL Set ID df1f8bda-7bf3-4755-9169-f2a81d824cbe
Route
NASAL
Published
Effective Date 2024-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (50 mg)
Inactive Ingredients
Polysorbate 80 Glycerin Propylene Glycol Edetate Disodium Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic Benzyl Alcohol Benzalkonium Chloride Water Menthol Camphor (synthetic) Eucalyptol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-30

Description

Active Ingredient Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Active Ingredient Oxymetazoline Hydrochloride 0.05%

Uses

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporaily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Section 51945-4

CVS Health Severe Congestion

Maximum Strength

Nasal Spray

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

Directions
  • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  • Wipe nozzle clean after use.
  • 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 consult a doctor.
Drug Facts

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Other Information
  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients

Benzalkonium Chloride Solution, Benzyl Alcohol, Camphor, Edetate Sodium, Eucalyptol, Glycerin, Menthol, Polysorbate 80, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

When Using This Product
  • Do not use more than directed
  • do not use for more than three 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.
Stop Use and Ask A Doctor if

symptoms persist.

If Pregnant Or Breast Feeding 

ask a health professional before use.

Keep Out of the Reach of Children

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

Ask A Doctor Before Use If You Have
  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

Structured Label Content

Uses

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporaily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Section 51945-4 (51945-4)

CVS Health Severe Congestion

Maximum Strength

Nasal Spray

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

Purpose

Nasal Decongestant

Directions
  • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  • Wipe nozzle clean after use.
  • 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 consult a doctor.
Drug Facts

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Other Information (Other information)
  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients

Benzalkonium Chloride Solution, Benzyl Alcohol, Camphor, Edetate Sodium, Eucalyptol, Glycerin, Menthol, Polysorbate 80, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

When Using This Product (When using this product)
  • Do not use more than directed
  • do not use for more than three 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.
Stop Use and Ask A Doctor if (stop use and ask a doctor if)

symptoms persist.

If Pregnant Or Breast Feeding  (if pregnant or breast-feeding )

ask a health professional before use.

Keep Out of the Reach of Children (Keep out of the reach of children)

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

Ask A Doctor Before Use If You Have (Ask a Doctor before use if you have)
  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

Advanced Ingredient Data


Raw Label Data

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