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Name:Naphazoline Hci And Pheniramine Maleate
Manufacturer:Altaire Pharmaceuticals Inc.
Category:Over-the-counter (OTC) Marketed Drugs


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

NAPHAZOLINE HCI AND PHENIRAMINE MALEATE  - naphazoline hydrochloride and 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

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:59390-177
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.027 mL  in 100 mL
PHENIRAMINE MALEATE (PHENIRAMINE) PHENIRAMINE MALEATE 0.315 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
BORIC ACID  
EDETATE DISODIUM  
HYPROMELLOSE  
WATER  
SODIUM BORATE  
SODIUM CHLORIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59390-177-13 15 mL in 1 BOTTLE, DROPPER None

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 Operations
Altaire Pharmaceuticals Inc. 786790378 manufacture

Revised: 10/2010 Altaire Pharmaceuticals Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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