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Mucinex Nasal Spray Prescribing Information

Package insert / product label
Generic name: oxymetazoline hydrochloride
Dosage form: nasal solution
Drug class: Nasal antihistamines and decongestants

Medically reviewed by Drugs.com. Last updated on Jul 22, 2022.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

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 membranes

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

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.

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 and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

Other information

  • store between 20-25°C (68-77°F)
  • retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride solution, edetate disodium, glycerin, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sorbitol

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 22 mL Carton

NDC 63824-122-75

Mucinex®
NASAL SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

Moisture
Smart
®

MEMBRANE HYDRATION
TECHNOLOGY
®

  • Soothes
    membranes & clears
    out excess mucus
  • Fast Relief
    of sinus pressure
    & nasal congestion

12
HOUR

3/4 FL OZ (22 mL)

MUCINEX NASAL MOISTURE SMART
oxymetazoline hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-122
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxymetazoline Hydrochloride (Oxymetazoline) Oxymetazoline Hydrochloride 0.5 mg in 1 mL
Packaging
# Item Code Package Description
1 NDC:63824-122-75 1 BOTTLE (BOTTLE) in 1 CARTON
1 22 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 06/30/2010
Labeler - Reckitt Benckiser, Inc. (094405024)
Reckitt Benckiser, Inc.