Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID d9ba3859-90af-0390-11be-c04834e27d61
Route
NASAL
Published
Effective Date 2025-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Budesonide (32 ug)
Inactive Ingredients
Edetate Disodium Carboxymethylcellulose Sodium, Unspecified Microcrystalline Cellulose Dextrose, Unspecified Form Potassium Sorbate Polysorbate 80 Hydrochloric Acid Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-07-01

Description

Budesonide (glucocorticoid) 32 mcg

Purpose

Nasal allergy symptom reliever


Medication Information

Purpose

Nasal allergy symptom reliever

Description

Budesonide (glucocorticoid) 32 mcg

Use

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

• nasal congestion • runny nose • itchy nose • sneezing

Section 53414-9

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

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
Do Not Use
  • in children under 6 years of age
  • if you have ever had an allergic reaction to any of the ingredients
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

Questions Or Comments?

1-888-287-1915

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
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
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).

Principal Display Panel Bottle

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Walmart NDC 49035-703-01

Budesonide Nasal Spray

Nasal Allergy Symptom Reliever

120 sprays

Principal Display Panel Carton

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Walmart NDC 49035-703-01

Budesonide Nasal Spray

Nasal Allergy Symptom Reliever

120 sprays

Relief of:

  • Nasal congestion
  • Runny nose
  • Itchy nose
  • Sneezing
Active Ingredient (in Each Spray)

Budesonide (glucocorticoid) 32 mcg


Structured Label Content

Use

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

• nasal congestion • runny nose • itchy nose • sneezing

Section 53414-9 (53414-9)

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

Purpose

Nasal allergy symptom reliever

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
Do Not Use (Do not use)
  • in children under 6 years of age
  • if you have ever had an allergic reaction to any of the ingredients
Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-888-287-1915

When Using This Product (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 (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
Ask A Doctor Before Use If You (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
Keep Out of Reach of Children. (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).

Principal Display Panel Bottle (Principal Display Panel - Bottle)

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Walmart NDC 49035-703-01

Budesonide Nasal Spray

Nasal Allergy Symptom Reliever

120 sprays

Principal Display Panel Carton (Principal Display Panel - Carton)

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Walmart NDC 49035-703-01

Budesonide Nasal Spray

Nasal Allergy Symptom Reliever

120 sprays

Relief of:

  • Nasal congestion
  • Runny nose
  • Itchy nose
  • Sneezing
Active Ingredient (in Each Spray) (Active ingredient (in each spray))

Budesonide (glucocorticoid) 32 mcg


Advanced Ingredient Data


Raw Label Data

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