NAPHAZOLINE HCI AND PHENIRAMINE MALEATE- naphazoline hydrochloride , pheniramine maleate solution/ drops 
Altaire Pharmaceuticals Inc.

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Naphazoline HCI 0.027% & Pheniramine Maleate 0.315% Ophthalmic Solution, USP

Active Ingredients

Naphazoline Hydrochloride (0.027%)

Pheniramine Maleate (0.315%)

Purpose

Redness Reliever

Antihistamine

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

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 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 a doctor before use if  you have

Remove contact lenses before using.

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.

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.

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.

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

Protect from light.

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 ingredients

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

Questions or comments

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

Manufactured by:

Altaire Pharmaceuticals, Inc.

Aquebogue, N.Y. 11931

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)

IL15

OL15

NAPHAZOLINE HCI AND PHENIRAMINE MALEATE 
naphazoline hydrochloride , pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59390-177
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.27 mg  in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE3.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59390-177-1315 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/06/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07820810/06/2010
Labeler - Altaire Pharmaceuticals Inc. (786790378)
Establishment
NameAddressID/FEIBusiness Operations
Altaire Pharmaceuticals Inc.786790378manufacture(59390-177)

Revised: 12/2020
Document Id: b78fd969-ee4c-0ea0-e053-2a95a90a480d
Set id: 5649c6e2-966f-44d9-b57e-5bb988eb373d
Version: 4
Effective Time: 20201228
 
Altaire Pharmaceuticals Inc.