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Astelin 137Mcg Nasal Spray Inhaler 1X30 ml Mfg.By: Meda Pharmaceuticals Inc Us

Image 0 of Astelin 137Mcg Nasal Spray Inhaler 1X30 ml Mfg.By: Meda Pharmaceuticals Inc UsImage 1 of Astelin 137Mcg Nasal Spray Inhaler 1X30 ml Mfg.By: Meda Pharmaceuticals Inc UsImage 2 of Astelin 137Mcg Nasal Spray Inhaler 1X30 ml Mfg.By: Meda Pharmaceuticals Inc Us

Astelin 137Mcg Nasal Spray Inhaler 1X30 ml Mfg.By: Meda Pharmaceuticals Inc Us

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Astelin 137Mcg Nasal Spray Inhaler 1X30 ml Mfg.By: Meda Pharmaceuticals Inc Us This Item Requires A Valid Order From A Physician Licensed in The USA. Item No.:RXD3565033/RXB10060421 Item Profile
#3565033
NDC No. 00037024130

Generic Name:Azelastine Hcl Trade Name: Astelin
Additional Description:Nsl 200Sp
Strength: 137Mcg. Form:Spin
Size 30 ml
Unit of Measure ml
Unit of Sale Each
Unit Dose
Schedule No. 0
Private Label 999
Multi-Source Y
Active Status Active
Generic

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DESCRIPTION

Astelin? (azelastine hydrochloride) Nasal Spray, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225?C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (?)-1-(2H)- phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1- methyl-1H-azepin-4-yl)-, monohydrochloride.

Astelin? Nasal Spray contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ? 0.3. It also contains benzalkonium chloride (125 mcg/mL), edetate disodium, hypromellose, citric acid, dibasic sodium phosphate, sodium chloride, and purified water.

After priming, each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays.

INDICATIONS

Astelin? Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older.
DOSAGE AND ADMINISTRATION
Seasonal Allergic Rhinitis

The recommended dose of Astelin? Nasal Spray in adults and children 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dose of Astelin? Nasal Spray in children 5 years to 11 years of age is one spray per nostril twice daily.
Vasomotor Rhinitis

The recommended dose of Astelin? Nasal Spray in adults and children 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.

Before initial use, the delivery system should be primed with 4 sprays or until a fine mist appears. When 3 or more days have elapsed since the last use, the pump should be reprimed with 2 sprays or until a fine mist appears.
CAUTION: Avoid spraying in the eyes.

Directions for Use: Illustrated patient instructions for proper use accompany each package of Astelin? Nasal Spray.