Naphazoline HCI And Pheniramine Maleate

Dosage form: solution/ drops
Ingredients: NAPHAZOLINE HYDROCHLORIDE 0.027mL in 100mL, PHENIRAMINE MALEATE 0.315mL in 100mL
Labeler: Altaire Pharmaceuticals Inc.
NDC Code: 59390-177

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)

NAPHAZOLINE HCI AND PHENIRAMINE MALEATE 
naphazoline hydrochloride , pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59390-177
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.027 mL  in 100 mL
PHENIRAMINE MALEATE (PHENIRAMINE) PHENIRAMINE MALEATE0.315 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
EDETATE DISODIUM 
HYPROMELLOSE 
WATER 
SODIUM BORATE  
SODIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:59390-177-1315 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07820810/06/2010
Labeler - Altaire Pharmaceuticals Inc. (786790378)
Establishment
NameAddressID/FEIOperations
Altaire Pharmaceuticals Inc.786790378manufacture

Revised: 10/2010
 
Altaire Pharmaceuticals Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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