PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


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

OTC - ACTIVE INGREDIENT SECTION.


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

INDICATIONS & USAGE SECTION.


Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runnynose itchy nose sneezing

DOSAGE & ADMINISTRATION SECTION.


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 childs 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

SPL UNCLASSIFIED SECTION.


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 25C (68 to 77F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.

INACTIVE INGREDIENT SECTION.


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

OTC - QUESTIONS SECTION.


Questions or comments? call toll free 1-800-706-5575

WARNINGS SECTION.


Warnings Do not use in children under 6 years of age if you have ever had an allergic reaction to anyof 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 yourdoctor about all the medicines you take, including this one Stop use and ask a doctor if youhave, 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.</paragraph </text </section </component 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).

OTC - PURPOSE SECTION.


Purpose Nasal allergy symptom reliever