NAPHAZOLINE HCI AND PHENIRAMINE MALEATE- naphazoline hydrochloride , pheniramine maleate solution/ drops

Naphazoline HCI And Pheniramine Maleate by

Drug Labeling and Warnings

Naphazoline HCI And Pheniramine Maleate by is a Otc medication manufactured, distributed, or labeled by Altaire Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Naphazoline Hydrochloride (0.027%)

Pheniramine Maleate (0.315%)

PURPOSE

Purpose

Redness Reliever

Antihistamine

INDICATIONS & USAGE

Uses: temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.

WARNINGS

Warnings: if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a physician. Do not use in children under 6 years of age unless directed by a physician. If this solution changes color or becomes cloudy, do not use. Overuse of this product may produce increased redness of the eye.

If you are sensitive to any ingredient in this product, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

DO NOT USE

Do not use if imprinted seal on cap is torn, broken or missing, or if imprinted seals on top ad bottom flaps are not intact and completely legible.

ASK DOCTOR

Ask a doctor before use if  you have

• heart disease
• high blood pressure
• trouble urinating due to enlarged prostrate gland
• narrow angle glaucoma
  

WHEN USING

Remove contact lenses before using.

STOP USE

Stop use and ask a doctor if you experience: eye pain, changes in vision, redness or irritation of the eye that worsens or persists for more than 72 hours. Overuse of this product may produce increased redness of the eye. Pupils may become enlarged temporarily. You may experience a brief tingling sensation after putting drops in eyes.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 6 years of age and older: instill 1 or 2 drops in affected eye(s) up to 4 times daily.

Children under 6 years: ask a doctor.

STORAGE AND HANDLING

Store at room temperature 20 degrees - 25 degrees C ( 68 degrees - 77 degrees F).

Protect from light.

SPL UNCLASSIFIED SECTION

Use before expiration date marked on the carton or bottle.

Available in 15mL NDC: 59390-177-13 and 30 mL NDC: 59390-177-18

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride 0.01%, boric acid, edetate disodium 0.1%, hypromellose, purified water, sodium borate, and sodium chloride.

QUESTIONS

Questions or comments

Call (631) 722-5988 9am - 5pm EST Monday - Friday

SPL UNCLASSIFIED SECTION

Manufactured by:

Altaire Pharmaceuticals, Inc.

Aquebogue, N.Y. 11931

PRINCIPAL DISPLAY PANEL

ALTAIRE Pharmaceuticals, Inc.

Aquebogue, N.Y. 11931

Naphazoline HCI 0.027%

and

Pheniramine Maleate 0.315%

Ophthalmic Solution, USP

Eye Allergy Relief

With Antihistamine To Relieve Itching

Itching and Redness Reliever
Eye Drops

0.5 Fl. OZ. (15mL)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAPHAZOLINE HCI AND PHENIRAMINE MALEATE 
naphazoline hydrochloride , pheniramine maleate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59390-177
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.27 mg  in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	3.15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59390-177-13	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/06/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078208	10/06/2010

Labeler - Altaire Pharmaceuticals Inc. (786790378)

Establishment
Name	Address	ID/FEI	Business Operations
Altaire Pharmaceuticals Inc.		786790378	manufacture(59390-177)