Mucinex®

Mucinex®
SPL v2
SPL
SPL Set ID 15d614f4-1dd4-46b8-90de-845bce86e400
Route
NASAL
Published
Effective Date 2010-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 mg)
Inactive Ingredients
Benzalkonium Chloride Camphor (synthetic) Edetate Disodium Eucalyptol Glycine Menthol Polyethylene Glycol Polysorbate 80 Propylene Glycol Water Sodium Chloride Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-06-30

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist

Section 50567-7

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
Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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.

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

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

benzalkonium chloride solution, camphor, edetate disodium, eucalyptol, glycine, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide

Principal Display Panel 22 Ml Bottle Carton

NDC 63824-123-75

Mucinex®

NASAL SPRAY

Oxymetazoline HCl 0.05%

Nasal Decongestant

FULL

FORCE


CONCENTRATED VAPOR

TECHNOLOGY®

  • Powerful

    mucus-moving

    sensation
  • Fast Relief

    of sinus pressure

    & nasal congestion

12

HOUR

3/4 FL OZ (22 mL)


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 membranes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist

Section 50567-7 (50567-7)

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
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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 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.

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride solution, camphor, edetate disodium, eucalyptol, glycine, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide

Principal Display Panel 22 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton)

NDC 63824-123-75

Mucinex®

NASAL SPRAY

Oxymetazoline HCl 0.05%

Nasal Decongestant

FULL

FORCE


CONCENTRATED VAPOR

TECHNOLOGY®

  • Powerful

    mucus-moving

    sensation
  • Fast Relief

    of sinus pressure

    & nasal congestion

12

HOUR

3/4 FL OZ (22 mL)


Advanced Ingredient Data


Raw Label Data

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