Budesonide

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Budesonide (glucocorticoid) 32 mcg

Purpose

OTC - PURPOSE SECTION

Nasal allergy symptom reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

• nasal congestion • runny nose • itchy nose • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Direction

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

• 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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-800-706-5575

Principal Display Panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rite Aid

Budesonide Nasal Spray

Allergy Spray

120 sprays

Relief of:

• Nasal Congestion
• Runny Nose
• Itchy Nose
• Sneezing

Principal Display Panel - Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rite Aid

Budesonide Nasal Spray

Allergy Spray

120 sprays

DailyMed Product Concepts#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

• Budesonide
• EDETATE DISODIUM
• CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
• MICROCRYSTALLINE CELLULOSE
• DEXTROSE, UNSPECIFIED FORM
• POTASSIUM SORBATE
• POLYSORBATE 80
• HYDROCHLORIC ACID
• WATER

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.