FDA Label for Budesonide

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

• 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 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

Carton-label-60ms - HVD60msCTN

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

Bottle-label-60ms - HVD60msLBL

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