Budesonide Spray, Metered
FDA Label NDC 49035-703

14 label sections · Submitted to the FDA by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) for the product Budesonide (NDC 49035-703). 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, 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., 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

→ 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.

→ Direction

→ 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

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).

Direction

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

Other Information

do not use if the safety seal labeled "sealedfor your protection" is broken or missing.
keep package and insert. They contain important information.
store 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