RHINOCORT ALLERGY- budesonide spray, metered

RHINOCORT Allergy by

Drug Labeling and Warnings

RHINOCORT Allergy by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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
• sneezing
• itchy nose

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 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 instructions (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 carton tape imprinted with "RHINOCORT" is broken or missing or if aluminum seal under unit cap and spray tip is damaged/broken/unsealed
• keep package and insert. They contain important information.
• store at 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions?

call 1-800-343-7805 (toll free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC: 50580-646-01

RHINOCORT®
ALLERGY
SPRAY

Budesonide (glucocorticoid)
Nasal spray, 32 mcg per spray
Nasal Allergy Symptom Reliever

24
HOUR
NON-DROWSY
RELIEF OF

• Nasal Congestion
• Runny Nose
• Itchy Nose
• Sneezing

60 SPRAYS
0.169 fl oz (5 ml)

INGREDIENTS AND APPEARANCE

RHINOCORT ALLERGY 
budesonide spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-646
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
budesonide (UNII: Q3OKS62Q6X) (budesonide - UNII:Q3OKS62Q6X)	budesonide	32 ug

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
anhydrous dextrose (UNII: 5SL0G7R0OK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
hydrochloric acid (UNII: QTT17582CB)
microcrystalline cellulose (UNII: OP1R32D61U)
polysorbate 80 (UNII: 6OZP39ZG8H)
potassium sorbate (UNII: 1VPU26JZZ4)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-646-01	1 in 1 CARTON	01/14/2016
1		60 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2	NDC: 50580-646-02	1 in 1 CARTON	01/14/2016
2		120 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
3	NDC: 50580-646-03	3 in 1 PACKAGE	01/14/2016
3	NDC: 50580-646-02	1 in 1 CARTON
3		120 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020746	01/14/2016

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)