Budesonide

Manufacturer: Rite Aid | Apotex Inc.
Effective date: 2017-12-19
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:06:14

Label at a glance#

ProductBudesonide

Active ingredientBudesonide

Label structure11 sections

Indications and uses

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

Dosage and administration

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 ...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-706-5575

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

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).

Directions

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

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

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

Carton-label

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

Bottle-label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11822-6000-6	2022-05-18	C162847	48780-1	ba0f9c33-2cdf-a910-e053-dadaa90a0b85	Drug Facts
11822-6000-6	2021-01-29	C162847	48780-1	ba0f9c33-2cdf-a910-e053-dadaa90a0b85	Drug Facts

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
CELLULOSE, MICROCRYSTALLINE
DEXTROSE
POTASSIUM SORBATE
POLYSORBATE 80
HYDROCHLORIC ACID
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11822-6000	11822-6000-6

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
Budesonide	Q3OKS62Q6X	ACTIB
EDETATE DISODIUM	7FLD91C86K	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
DEXTROSE	IY9XDZ35W2	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
WATER	059QF0KO0R	IACT

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.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078949-002	BUDESONIDE	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL			2015-11-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`f41ea6bd6efb…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a0919e48-2839-aa40-2b7c-28adfd10967a			39c0c82b-f969-f2c6-143e-3108cdb66591	2022-05-18	Warnings	Exact identifier spl set id: 39c0c82b-f969-f2c6-143e-3108cdb66591

Reported adverse events (FAERS/openFDA)#

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