Quality Choice 12 Hour Relief Nasal Spray Drug Facts

Quality Choice 12 Hour Relief Nasal Spray Drug Facts
SPL v6
SPL
SPL Set ID d01b8fb6-1ddf-4901-bda6-ae608e94a6a4
Route
NASAL
Published
Effective Date 2019-02-01
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 2018-12-17

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
  • hay fever
  • upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen nasal membranes
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

Shake well before use:Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap.

Rotate the lock tab to align arrow marks to unlock the pump. Prime the lock tab to align arrow marks to unlock the pump. Prime metered pump by depressing pump firmly several times.

To spray, hold bottle with thump at base and nozzle 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. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store at room temperature
  • retain carton for future reference on full labeling
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

NDC# 63868-699-22

QUALITY CHOICE ®

* Compare to Active Ingredient in Mucinex® Full Force Nasal Spray

12 Hour Relief

Nasal Spray

Nasal Decongestant

Oxymetazoline HCl 0.05%

Fast Relief of Sinus Pressure & Nasal Congestion

3/4 FL OZ (22 mL)

100% QC SATISFACTION GUARANTEED

Distributed by C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ®Full Force™ Nasal Spray.

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 (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

Structured Label Content

Uses

temporarily relieves nasal congestion due to:

  • a cold
  • hay fever
  • upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen nasal membranes
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

Shake well before use:Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap.

Rotate the lock tab to align arrow marks to unlock the pump. Prime the lock tab to align arrow marks to unlock the pump. Prime metered pump by depressing pump firmly several times.

To spray, hold bottle with thump at base and nozzle 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. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store at room temperature
  • retain carton for future reference on full labeling
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

NDC# 63868-699-22

QUALITY CHOICE ®

* Compare to Active Ingredient in Mucinex® Full Force Nasal Spray

12 Hour Relief

Nasal Spray

Nasal Decongestant

Oxymetazoline HCl 0.05%

Fast Relief of Sinus Pressure & Nasal Congestion

3/4 FL OZ (22 mL)

100% QC SATISFACTION GUARANTEED

Distributed by C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ®Full Force™ Nasal Spray.

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 (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)