Naphazoline Hci 0.027% & Pheniramine Maleate 0.315% Ophthalmic Solution, Usp

Naphazoline Hci 0.027% & Pheniramine Maleate 0.315% Ophthalmic Solution, Usp
SPL v4
SPL
SPL Set ID 5649c6e2-966f-44d9-b57e-5bb988eb373d
Route
OPHTHALMIC
Published
Effective Date 2010-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naphazoline (0.27 mg) Pheniramine (3.15 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Edetate Disodium Hypromellose, Unspecified Water Sodium Borate Sodium Chloride

Identifiers & Packaging

Marketing Status
ANDA Active Since 2010-10-06

Description

Active Ingredients Naphazoline Hydrochloride (0.027%) Pheniramine Maleate (0.315%)


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

Dosage and 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.

Description

Active Ingredients Naphazoline Hydrochloride (0.027%) Pheniramine Maleate (0.315%)

Section 42229-5

Use before expiration date marked on the carton or bottle.

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

Section 44425-7

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

Protect from light.

Section 50565-1

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.

Section 50566-9

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.

Section 50567-7

Remove contact lenses before using.

Section 50569-3

Ask a doctor before use if  you have

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

Section 50570-1

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.

Section 51727-6

Inactive ingredients

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

Section 51945-4

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)

Section 53413-1

Questions or comments

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

Section 55105-1

Purpose

Redness Reliever

Antihistamine

Section 55106-9

Active Ingredients

Naphazoline Hydrochloride (0.027%)

Pheniramine Maleate (0.315%)


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Use before expiration date marked on the carton or bottle.

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

Section 44425-7 (44425-7)

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

Protect from light.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

Remove contact lenses before using.

Section 50569-3 (50569-3)

Ask a doctor before use if  you have

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

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)

Section 53413-1 (53413-1)

Questions or comments

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

Section 55105-1 (55105-1)

Purpose

Redness Reliever

Antihistamine

Section 55106-9 (55106-9)

Active Ingredients

Naphazoline Hydrochloride (0.027%)

Pheniramine Maleate (0.315%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)