NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE solution/ drops

Naphazoline Hydrochloride and Pheniramine Maleate by

Drug Labeling and Warnings

Naphazoline Hydrochloride and Pheniramine Maleate by is a Otc medication manufactured, distributed, or labeled by Akorn, Inc., Akorn, Inc, Akorn, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Naphazoline Hydrochloride 0.025%

Pheniramine Maleate 0.3%

Purpose

Redness reliever

Antihistamine

Uses

Temporarily relieves itchy, red eyes due to:

• pollen
• ragweed
• grass
• animal hair and dander

Warnings:

For external use only

Do not use if you are sensitive to any ingredient in this product

Ask a doctor before use if you have

• heart disease
• high blood pressure
• narrow angle glaucoma
• trouble urinating

When using this product

• pupils may become enlarged temporarily causing light sensitivity
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use
• remove contact lenses before using
• do not use if this solution changes color or become cloudy
• overuse may cause more eye redness
• some users may experience a brief tingling sensation

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens or lasts more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

Directions

• adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to four times a day
• children under 6 years of age: consult a doctor

Other information

• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Boric Acid and Sodium Borate buffer system preserved with Benzalkonium Chloride (0.01%) and Edetate Disodium (0.1%), Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Water for Injection.

Questions?

Call toll-free

1-800-932-5676

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 17478-065-12

Naphazoline HCl 0.025%

and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

ANTIHISTAMINE & REDNESS

RELIEVER

Eye Allergy

Relief Eye Drops

Sterile

15 mL (0.5 fl. oz.)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 17478-065-12

Naphazoline HCl 0.025%

and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

ANTIHISTAMINE & REDNESS

RELIEVER

Eye Allergy

Relief Eye Drops

► Relieves Redness

► Relieves itchy Eyes Due To:

Pollen ● Ragweed ● Grass

Animal Hair & Dander

Sterile

15 mL (0.5 fl. oz.)

INGREDIENTS AND APPEARANCE

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE 
naphazoline hydrochloride and pheniramine maleate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17478-065
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV)	Naphazoline Hydrochloride	0.25 mg  in 1 mL
Pheniramine Maleate (UNII: NYW905655B) (Pheniramine - UNII:134FM9ZZ6M)	Pheniramine Maleate	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Boric Acid (UNII: R57ZHV85D4)
Sodium Borate (UNII: 91MBZ8H3QO)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17478-065-12	1 in 1 CARTON	01/24/2013
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202795	01/24/2013

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		063434679	PACK(17478-065) , LABEL(17478-065)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		155135783	MANUFACTURE(17478-065) , ANALYSIS(17478-065) , STERILIZE(17478-065)