Mucinex Childrens Stuffy Nose Solution
FDA Label NDC 63824-961

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens Stuffy Nose (NDC 63824-961). 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 other, active ingredient, purpose, uses, otc - ask doctor, when using this product, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Made in India

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to:
    • a cold
    • hay fever or other 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 or the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

When Using This Product

  • do not exceed recommended dosage
  • do not use this product for more than 3 days.
    Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
  • this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
  • the use of this container by more than one person may spread infection

Otc - Stop Use

Stop use and ask a doctor if symptoms persist

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

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: consult a doctor.

    • Shake well before use. To open, hold by the white grips then squeeze and turn cap. Before using for 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 the 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. To close, turn cap until it "clicks".

    DO NOT DISCARD CAP

Other Information

  • store between 20-25°C (68-77°F)

Inactive Ingredients

benzalkonium chloride, 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 number.

Principal Display Panel - 22 Ml Bottle Carton

NDC 63824-961-22

Mucinex®

Children's

STUFFY NOSE
SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

12
HOUR

  • ✓Fast Relief
    of Stuffy Nose

    • Ages 6+
    yrs

    3/4 FL OZ (22 mL)
    NASAL SPRAY

    Principal Display Panel (22 mL Bottle Carton)

    Principal Display Panel (22 mL Bottle Carton)

* Please review the disclaimer below.