1. Home
  2. Labeler Index
  3. Rb Health (us) Llc
  4. 63824-961
  5. Label Information: Mucinex Childrens Stuffy Nose

FDA Label for Mucinex Childrens Stuffy Nose

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. OTC - ASK DOCTOR
    6. WHEN USING THIS PRODUCT
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 22 ML BOTTLE CARTON

Mucinex Childrens Stuffy Nose Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

* Please review the disclaimer below.