SPL v3
SPL
SPL Set ID e9c551a0-cd78-4272-b42f-36c096d26736
Route
NASAL
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Polyethylene Glycol 300 Glycerin Propylene Glycol Edetate Disodium Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic, Anhydrous Povidone Benzalkonium Chloride Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-30

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:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely
Section 53414-9

ask a health professional before use.

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 consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
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, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

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.

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
  • thyroid disease
  • trouble urinating due to enlarged prostate gland
Principal Display Panel Carton Label

CVS Original Nasal Spray NDC 51316-140-30

Oxymetazoline Hydrochloride 0.05%

12 hour Nasal Mist

Nasal Decongestant

NET WT 1.0 FLOZ (30ml)

 principal Display Panel Bottle Label

CVS Original Nasal Spray          NDC 51316-140-30

Oxymetazoline Hydrochloride 0.05%

12 hour Nasal Mist

Nasal Decongestant

NET WT 1.0 FLOZ (30ml)


Structured Label Content

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely
Section 53414-9 (53414-9)

ask a health professional before use.

Purpose

Nasal Decongestant

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 consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
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, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

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.

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
  • thyroid disease
  • trouble urinating due to enlarged prostate gland
Principal Display Panel Carton Label (Principal Display panel - Carton label)

CVS Original Nasal Spray NDC 51316-140-30

Oxymetazoline Hydrochloride 0.05%

12 hour Nasal Mist

Nasal Decongestant

NET WT 1.0 FLOZ (30ml)

 principal Display Panel Bottle Label ( Principal Display panel - Bottle label)

CVS Original Nasal Spray          NDC 51316-140-30

Oxymetazoline Hydrochloride 0.05%

12 hour Nasal Mist

Nasal Decongestant

NET WT 1.0 FLOZ (30ml)


Advanced Ingredient Data


Raw Label Data

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