Otc - Active Ingredient
Active Ingredients
Naphazoline Hydrochloride (0.027%)
Pheniramine Maleate (0.315%)
Naphazoline Hci And Pheniramine Maleate Solution/ Drops
FDA Label NDC 59390-177
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Altaire Pharmaceuticals Inc. for the product Naphazoline Hci And Pheniramine Maleate (NDC 59390-177). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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.
Otc - 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
Otc - When Using
Remove contact lenses before using.
Otc - 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.
Otc - 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.
Other
Use before expiration date marked on the carton or bottle.
Available in 15mL NDC 59390-177-13 and 30 mL NDC 59390-177-18
Manufactured by:
Altaire Pharmaceuticals, Inc.
Aquebogue, N.Y. 11931
Inactive Ingredient
Inactive ingredients
benzalkonium chloride 0.01%, boric acid, edetate disodium 0.1%, hypromellose, purified water, sodium borate, and sodium chloride.
Otc - Questions
Questions or comments
Call (631) 722-5988 9am - 5pm EST Monday - Friday
Package Label.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)
Il15 (Naphazolinelabel)
Ol15 (Naphazolineboxlabel)
* Please review the disclaimer below.
