Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 04eb9e98-1323-353f-3fd7-2d317dfac526
Route
NASAL
Published
Effective Date 2024-10-02
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 Completed Since 2016-07-27 Until 2027-06-30
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.

Warnings

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
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 "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

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

Questions Or Comments?

call toll free 1-800-645-2158

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).

Active Ingredient (in Each Spray)

Budesonide (glucocorticoid) 32 mcg

Principal Display Panel Bottle 120ms

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-48

Budesonide Nasal Spray

Allergy Spray

120 sprays

Principal Display Panel Carton 120ms

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-48

Budesonide Nasal Spray

Allergy Spray

120 sprays

Relief of:

  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

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

Warnings

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
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 "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 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?)

call toll free 1-800-645-2158

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).

Active Ingredient (in Each Spray) (Active ingredient (in each spray))

Budesonide (glucocorticoid) 32 mcg

Principal Display Panel Bottle 120ms (Principal Display Panel - Bottle 120ms)

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-48

Budesonide Nasal Spray

Allergy Spray

120 sprays

Principal Display Panel Carton 120ms (Principal Display Panel - Carton 120ms)

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-48

Budesonide Nasal Spray

Allergy Spray

120 sprays

Relief of:

  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:40.788087 · Updated: 2026-03-14T23:13:57.106193