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NDC 60505-6194-03 Budesonide 32 ug/1 Details

Budesonide 32 ug/1

Budesonide is a NASAL SPRAY, METERED in the HUMAN OTC DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is BUDESONIDE.

MedlinePlus Drug Summary

Budesonide nasal spray is used to relieve sneezing, runny, stuffy, or itchy nose caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Budesonide nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold. Budesonide nasal spray is in a class of drugs called corticosteroids. It works by blocking the release of certain natural substances that cause allergy symptoms.

Related Packages: 60505-6194-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Budesonide Nasal Spray

Product Information

NDC	60505-6194
Product ID	60505-6194_08cf739d-267d-26ce-3128-6f460c8470c7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Budesonide
Proprietary Name Suffix	n/a
Non-Proprietary Name	Budesonide
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY, METERED
Route	NASAL
Active Ingredient Strength	32
Active Ingredient Units	ug/1
Substance Name	BUDESONIDE
Labeler Name	Apotex Corp.
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078949
Listing Certified Through	2023-12-31

Package

Package Images

NDC 60505-6194-03 (60505619403)

Pricing Information	N/A
NDC Package Code	60505-6194-3
Billing NDC	60505619403
Package	1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (60505-6194-3) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Marketing Start Date	2018-04-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1c4bdbe3-f3d1-8dac-83ee-b31be5acf6c9 Details

Active ingredient (in each spray)

Budesonide (glucocorticoid) 32 mcg

Purpose

Nasal allergy symptom reliever

Uses

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

• nasal congestion • runny nose • itchy nose • sneezing

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 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).

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

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 upright 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 1-800-706-5575

Principal Display Panel - Carton

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

APOTEX CORP. NDC 60505-6194-3

Budesonide Nasal Spray

Allergy Spray

120 sprays

Relief of:

Nasal Congestion
Runny Nose
Itchy Nose
Sneezing

Principal Display Panel - Bottle

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray