Cvs Health™

Cvs Health™
SPL v1
SPL
SPL Set ID 3e15a1f9-c93e-4cdb-865c-68bfa63d3323
Route
NASAL
Published
Effective Date 2016-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.00050 g)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Camphor (natural) Edetate Disodium Eucalyptol Menthol Polysorbate 80 Propylene Glycol Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate, Monobasic, Anhydrous Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-21

Description

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Oxymetazoline hydrochloride 0.05%

Uses
  • for the temporary relief of sinus/ nasal congestion due to:
  • colds
  • hay fever
  • upper respiratory allergies
Directions
  • adults and children 6 yrs, & older (with adult supervision): 2 or 3 sprays in each nostril without tilting your head, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 hours.
  • children 2 to under 6 yrs : ask a doctor
  • children under 2 yrs: Do not 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

Principal Display Panel

CVS Health

Compare to the active ingredient in Vicks® Sinex® *

Nasal Spray

Sinus Relief

OXYMETAZOLINE HCl 0.05%

Nasal decongestant

12 HOUR

NASAL SPRAY FOR SINUS RELIEF

12 Hour

1/2 FL OZ (15 mL)

DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSNG

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks®Sinex®

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2015 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

V-12431

CVS Quality

Money Back Guarantee

When Using This Product
  • do not exceed recommended dosage
  • use of this container by more than one person may spread infection.
  • temporary burning, stinging, sneezing or increase in nasal discharge may occur
  • frequent or prolonged use may cause nasal congestion to recur or worsen
Stop Use and Ask A Doctor

If Symptoms persist for more than 3 days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away. ( 1-800-222-1222)

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

Structured Label Content

Uses
  • for the temporary relief of sinus/ nasal congestion due to:
  • colds
  • hay fever
  • upper respiratory allergies
Purpose

Nasal Decongestant

Directions
  • adults and children 6 yrs, & older (with adult supervision): 2 or 3 sprays in each nostril without tilting your head, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 hours.
  • children 2 to under 6 yrs : ask a doctor
  • children under 2 yrs: Do not 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

Principal Display Panel

CVS Health

Compare to the active ingredient in Vicks® Sinex® *

Nasal Spray

Sinus Relief

OXYMETAZOLINE HCl 0.05%

Nasal decongestant

12 HOUR

NASAL SPRAY FOR SINUS RELIEF

12 Hour

1/2 FL OZ (15 mL)

DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSNG

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks®Sinex®

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2015 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

V-12431

CVS Quality

Money Back Guarantee

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • use of this container by more than one person may spread infection.
  • temporary burning, stinging, sneezing or increase in nasal discharge may occur
  • frequent or prolonged use may cause nasal congestion to recur or worsen
Stop Use and Ask A Doctor (Stop use and ask a doctor)

If Symptoms persist for more than 3 days

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.)

In case of accidental ingestion, get medical help or contact a Poison Control Center right away. ( 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
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)