BUDESONIDE spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUDESONIDE (UNII: Q3OKS62Q6X) (Budesonide - UNII:Q3OKS62Q6X)

Available from:

Amerisource Bergen

INN (International Name):

Budesonide

Composition:

Budesonide 32 ug

Administration route:

NASAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nasal allergy symptom reliever Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE- BUDESONIDE SPRAY, METERED
AMERISOURCE BERGEN
----------
DRUG FACTS
_ACTIVE INGREDIENT (IN EACH SPRAY)_
Budesonide (glucocorticoid) 32 mcg
_PURPOSE_
Nasal allergy symptom reliever
_USES_
Temporarily relieves these symptoms of hay fever or other upper
respiratory allergies:
• nasal congestion • runny nose • itchy nose • sneezing
_WARNINGS_
DO NOT USE
in children under 6 years of age
if you have ever had an allergic reaction to any of the ingredients
ASK A DOCTOR BEFORE USE IF YOU
have had recent nose ulcers or nose surgery
have had a nose injury that has not healed
are using a steroid medicine for asthma, allergies or skin rash
have an eye infection
have or had glaucoma or cataracts
WHEN USING THIS PRODUCT
the growth rate of some children may be slower
some symptoms may get better on the first day of treatment. It may
take up to two
weeks of daily use to feel the most symptom relief.
do not share this bottle with anyone else as this may spread germs
remember to tell your doctor about all the medicines you take,
including this one
STOP USE AND ASK A DOCTOR IF
you have, or come into contact with someone who has, chickenpox,
measles or
tuberculosis
you have or develop symptoms of an infection such as persistent fever
you have any change in vision
you have severe or frequent nosebleeds
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away (1-
800-222-1222).
_DIRECTIONS_
Read insert (inside package) on how to:
get a new bottle ready (primed) before first use
prime bottle again if not used for two days
use the spray
clean the spray nozzle
ADULTS AND CHILDREN 12 YEARS OF
AGE AND OLDER
adults
and
children
12 years
of age
and older
once daily, spray 2 times into
each nostril while sniffing
gently
once your allergy symptoms
improve, reduce to 1 spray in
each nostril per day
CHILDREN 6 TO UNDER 12 YEARS OF
AGE
the growth rate of some children may be
slower while using this produ