Budesonide Spray, Metered
FDA Label NDC 0363-0048

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Budesonide (NDC 0363-0048). 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 (in each spray), purpose, uses, warnings, do not use, ask a doctor before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Spray)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - Carton

→ Principal Display Panel - Bottle

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

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 product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year
children 6 to under 12 years of age	an adult should supervise use once daily, spray 1 time into each nostril while sniffing gently if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day
children under 6 years of age	do not use
do not use more than directed if you forget a dose, do not double the next dose do not spray into eyes or mouth if allergy symptoms do not improve after two weeks, stop using and talk to a doctor do not use for the common cold shake well before each use

Other Information

do not use if the safety seal labeled "sealed for your protection" is broken or missing.
keep package and insert. They contain important information.
store upright at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.

Inactive Ingredients

carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified water