Cvs Health ™

Cvs Health ™
SPL v8
SPL
SPL Set ID 89168715-71b1-424e-8dae-fcfa90bc85bf
Route
NASAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Camphor (natural) Edetate Disodium Eucalyptol Menthol, Unspecified Form Polysorbate 80 Propylene Glycol Water Sodium Phosphate, Dibasic, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-12

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, heavy fever, or other upper respiratory allergies
  • Sinus congestion and pressure
Directions
  • adults & children 6 years & older (with adult supervision):2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children 2 to under 6 years:ask a doctor
  • Children 2 years:do not use

To Use:Shake well before use .Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers without titling head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store at room temperature
Inactive Ingredients

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

CVS Health

Compare to the active ingredient in Vicks® Sinex™ Severe Original*

Ultra-Fine Mist

12 HOUR

Sinus Relief

OXYMETAZOLINE HCl 0.05%

Nasal decongestant

FOR SINUS RELIEF

  • Fast acting day/night relief
  • Moisturizing
  • Cold & allergy congestion
  • Sinus pressure
  • Ultra fine pump mist

Actual Bottle Size on Side Panel

IMPORTANT: KEEP THE CARTON FOR FUTURE REFERENCE ON FULL LABELING

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2019 CVS/pharmacy

CVS.com

1-800-SHOP CVS, V-12431

  • CVS Quality

    Money Back Guarantee

    Package contains One Bottle B

*This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks ®Sinex™ Severe Original.

PACKAGE LABEL 15 mL

When Using This Product
  • do not exceed recommended dosage
  • do not use this product 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
Stop Use and Ask A Doctor If
  • symptoms persist
Package Label Twin Pack 30 Ml
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

Uses

temporarily relieves

  • nasal congestion due to a cold, heavy fever, or other upper respiratory allergies
  • Sinus congestion and pressure
Purpose

Nasal Decongestant

Directions
  • adults & children 6 years & older (with adult supervision):2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children 2 to under 6 years:ask a doctor
  • Children 2 years:do not use

To Use:Shake well before use .Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers without titling head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

CVS Health

Compare to the active ingredient in Vicks® Sinex™ Severe Original*

Ultra-Fine Mist

12 HOUR

Sinus Relief

OXYMETAZOLINE HCl 0.05%

Nasal decongestant

FOR SINUS RELIEF

  • Fast acting day/night relief
  • Moisturizing
  • Cold & allergy congestion
  • Sinus pressure
  • Ultra fine pump mist

Actual Bottle Size on Side Panel

IMPORTANT: KEEP THE CARTON FOR FUTURE REFERENCE ON FULL LABELING

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2019 CVS/pharmacy

CVS.com

1-800-SHOP CVS, V-12431

  • CVS Quality

    Money Back Guarantee

    Package contains One Bottle B

*This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks ®Sinex™ Severe Original.

PACKAGE LABEL 15 mL

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • do not use this product 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms persist
Package Label Twin Pack 30 Ml (Package Label Twin Pack 30 mL)
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 at (1-800-222-1222).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data


Raw Label Data

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