MUCINEX CHILDRENS STUFFY NOSE- oxymetazoline hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY)

Available from:

RB Health (US) LLC

Administration route:

NASAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nasal decongestant - temporarily relieves nasal congestion due to: a cold hay fever or other upper respiratory allergies - 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

Authorization status:

OTC monograph final

Summary of Product characteristics

MUCINEX CHILDRENS STUFFY NOSE- OXYMETAZOLINE HYDROCHLORIDE SOLUTION
RB HEALTH (US) LLC
_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._
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MUCINEX® CHILDREN'S STUFFY NOSE SPRAY
_DRUG FACTS_
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
WARNINGS
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
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: 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,