NDC 0536-1112 Budesonide
Spray, Metered Nasal
Product Information
What is NDC 0536-1112?
The NDC code 0536-1112 is assigned by the FDA to the product Budesonide which is a human over the counter drug product labeled by Rugby Laboratories. The product's dosage form is spray, metered and is administered via nasal form. The product is distributed in 2 packages with assigned NDC codes 0536-1112-40 1 bottle, spray in 1 carton / 60 spray, metered in 1 bottle, spray, 0536-1112-48 1 bottle, spray in 1 carton / 120 spray, metered in 1 bottle, spray. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Budesonide?
Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed.
Product Packages
NDC Code 0536-1112-40
Package Description: 1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
NDC Code 0536-1112-48
Package Description: 1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Price per Unit: $1.59462 per ML
Product Details
What are Budesonide Active Ingredients?
- BUDESONIDE 32 ug/1 - A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.
Budesonide Active Ingredients UNII Codes
- BUDESONIDE (UNII: Q3OKS62Q6X)
- BUDESONIDE (UNII: Q3OKS62Q6X) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1797929 - budesonide 32 MCG/ACTUAT Metered Dose Nasal Spray
- RxCUI: 1797929 - budesonide 0.032 MG/ACTUAT Metered Dose Nasal Spray
Budesonide Inactive Ingredients UNII Codes
- EDETATE DISODIUM (UNII: 7FLD91C86K)
- CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- DEXTROSE (UNII: IY9XDZ35W2)
- POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- HYDROCHLORIC ACID (UNII: QTT17582CB)
- WATER (UNII: 059QF0KO0R)
Pharmacologic Class(es)
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Patient Education
Budesonide Nasal Spray
Budesonide Nasal Spray is pronounced as (byoo des' oh nide)
Why is budesonide nasal spray medication prescribed?
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 pe...
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* Please review the disclaimer below.
Budesonide Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- ACTIVE INGREDIENT (IN EACH SPRAY)
- PURPOSE
- USES
- WARNINGS
- 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.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - CARTON 60MS
- PRINCIPAL DISPLAY PANEL - CARTON 120MS
- PRINCIPAL DISPLAY PANEL - BOTTLE 60MS
- PRINCIPAL DISPLAY PANEL - BOTTLE 120MS
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
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
- 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
- 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
- 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
- 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
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER | |
adults and children 12 years of age and older | |
CHILDREN 6 TO UNDER 12 YEARS OF AGE | |
children 6 to under 12 years of age | |
children under 6 years of age | |
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 1-800-706-5575
Principal Display Panel - Carton 60Ms
CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray
Rugby Laboratories NDC 0536-1112-40
Budesonide Nasal Spray
Allergy Spray
60 sprays
Relief of:
- Nasal Congestion
- Runny Nose
- Itchy Nose
- Sneezing
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
Principal Display Panel - Bottle 60Ms
BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray
Rugby Laboratories NDC 0536-1112-40
Budesonide Nasal Spray
Allergy Spray
60 sprays
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
* Please review the disclaimer below.