Mucinex
FDA Label NDC 63824-123

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rb Health (us) Llc for the product Mucinex (NDC 63824-123). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, otc - ask doctor, otc - when using, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - When Using

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

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

Questions?

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

You may also report side effects to this phone number.

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)

    Principal Display Panel (22 mL Bottle Carton)

    Principal Display Panel (22 mL Bottle Carton)

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