NASAL ALLERGY 24 HOUR- triamcinolone acetonide spray, metered

NASAL Allergy 24 Hour by

Drug Labeling and Warnings

NASAL Allergy 24 Hour by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn Inc., Teva Pharmaceuticals USA Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each spray)

Triamcinolone acetonide (glucocorticoid) 55 mcg

Purpose

Nasal allergy symptom reliever

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)

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 2 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 one week 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 a 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 more than 2 weeks
• ■ 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 2 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 2 to under 6 years of age	■ an adult should supervise use ■ once daily, spray 1 time into each nostril while sniffing gently
children under 2 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 one week, 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 sealed package is torn or opened
• ■ keep package and insert. They contain important information.
• ■ store between 20°-25°C (68°-77°F)

Inactive ingredients

benzalkonium chloride, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid or sodium hydroxide (for pH adjustment), microcrystalline cellulose, polysorbate 80, purified water

Questions or comments?

1-888-838-2872

Package/Label Principal Display Panel

NASAL Allergy 24 HOUR Carton Text

Original Prescription Strength

Compare to Nasacort® Allergy 24 HR active ingredient

NDC: 50804-085-17

Multi-Symptom ·Nasal Allergy Spray

NASAL

Allergy 24 HOUR

Triamcinolone Acetonide (Glucocorticoid)

55 mcg Per Spray/Nasal Allergy Symptom Reliever

24 HR RELIEF OF:

•   Nasal Congestion
•   Sneezing
•   Runny Nose
•   Itchy Nose

120 Sprays

0.57 FL OZ (16.9 mL)

INGREDIENTS AND APPEARANCE

NASAL ALLERGY 24 HOUR 
triamcinolone acetonide spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-085
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)	TRIAMCINOLONE ACETONIDE	55 ug

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-085-17	1 in 1 CARTON
1		120 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078104	06/19/2015

Labeler - Geiss, Destin & Dunn Inc. (076059836)

Registrant - Teva Pharmaceuticals USA Inc (001627975)