Quality Choice Nasal Spray Drug Facts

Quality Choice Nasal Spray Drug Facts
SPL v3
SPL
SPL Set ID b5aa76eb-acc8-495f-85c9-bfdbb2d80e2a
Route
NASAL
Published
Effective Date 2022-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (.05 g)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Camphor (natural) Edetate Disodium Eucalyptol Glycerin Menthol, Unspecified Form Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sodium Phosphate, Dibasic, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-04-16

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
    • hey fever
    • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely
Directions
  • adults and children 6 to under 12 years of age (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 under 6 years of age: ask a doctor

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 rim between first and second fingers. Without tilting 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

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING

How to use:

Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

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
Stop Use and Ask A Doctor If

symptoms persist

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
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Package/label Principal Display Panel

QUALITY CHOICE®

NDC# 63868-080-01

*Compare to Active Ingredient Afrin® No Drip Severe Congestion

12 hour relief

Nasal Mist No Drip

Severe Congestion

Oxymetazoline HCl 0.05%

Nasal Solution

Fast and Powerful Congestion Relief

For Colds & Allergies

No Drip Pump Mist Won’t Drip from Nose or Down Throat

Maximum Strength

Plus Menthol

Unique Formula with Menthol

1 FL OZ (30mL)

100% QC SATISFACTION GURANTEED

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 800-935-2362

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Severe Congestion.


Structured Label Content

Uses
  • temporarily relieves nasal congestion due to:
    • common cold
    • hey fever
    • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely
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 often 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

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 rim between first and second fingers. Without tilting 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

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING

How to use:

Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

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
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 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
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Package/label Principal Display Panel (Package/Label Principal Display Panel)

QUALITY CHOICE®

NDC# 63868-080-01

*Compare to Active Ingredient Afrin® No Drip Severe Congestion

12 hour relief

Nasal Mist No Drip

Severe Congestion

Oxymetazoline HCl 0.05%

Nasal Solution

Fast and Powerful Congestion Relief

For Colds & Allergies

No Drip Pump Mist Won’t Drip from Nose or Down Throat

Maximum Strength

Plus Menthol

Unique Formula with Menthol

1 FL OZ (30mL)

100% QC SATISFACTION GURANTEED

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 800-935-2362

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Severe Congestion.


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