DailyMed - BUDESONIDE spray, metered

NDC Code(s): 60505-6129-2, 60505-6129-6, 60505-6129-7
Packager: Apotex Corp.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 29, 2024

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Active ingredient (in each spray)
Budesonide (glucocorticoid) 32 mcg

Budesonide (glucocorticoid) 32 mcg
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Purpose
Nasal allergy symptom reliever

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

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

• nasal congestion • runny nose • itchy nose • sneezing
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Warnings
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 ...
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
If pregnant or breast-feeding, ask a health professional before use.

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).

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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 ...

Other information
do not use if carton seals are broken. 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 ...
- do not use if carton seals are broken.
- 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.
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Inactive ingredients
carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified ...

carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified water
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Questions or comments?
call toll free 1-800-706-5575

call toll free 1-800-706-5575
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Principal Display Panel - Carton
CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray - APOTEX CORP. NDC 60505-6129-2 - Budesonide Nasal Spray - Allergy Spray - 120 sprays - Relief of: Nasal Congestion - Runny ...
CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

APOTEX CORP. NDC 60505-6129-2

Budesonide Nasal Spray

Allergy Spray

120 sprays

Relief of:
- Nasal Congestion
- Runny Nose
- Itchy Nose
- Sneezing
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Principal Display Panel - Bottle
BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray - APOTEX CORP. NDC 60505-6129-2 - Budesonid Nasal Spray - Allergy Spray - 120 sprays

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

APOTEX CORP. NDC 60505-6129-2

Budesonid Nasal Spray

Allergy Spray

120 sprays

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INGREDIENTS AND APPEARANCE

Product Information

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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

Published Date (What is this?)	Version	Files
Apr 30, 2024	7 (current)	download
Nov 6, 2023	6	download
Nov 21, 2022	5	download
Feb 11, 2020	4	download
Feb 3, 2020	3	download
Dec 7, 2017	2	download
Apr 21, 2016	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1797929	budesonide 32 MCG/ACTUAT Metered Dose Nasal Spray	PSN
2	1797929	budesonide 0.032 MG/ACTUAT Metered Dose Nasal Spray	SCD
3	1797929	budesonide 32 MCG/ACTUAT Metered Dose Nasal Spray	SY

Label: BUDESONIDE spray, metered

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	60505-6129-2
2	60505-6129-6
3	60505-6129-7

Label: BUDESONIDE spray, metered

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

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.

Find additional resources

Safety

Related Resources

More Info on this Drug

BUDESONIDE spray, metered

Number of versions: 7

BUDESONIDE spray, metered

BUDESONIDE spray, metered

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BUDESONIDE spray, metered

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.