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 CVS Pharmacy, 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 due to an enlarged prostate gland

When using this product

• pupils may become enlarged temporarily
• 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 becomes cloudy
• overuse may cause more eye redness

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

• some users may experience a brief tingling sensation
• 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 Hydroxide and/or Hydrochloric Acid (to adjust pH) and Water for injection.

Questions or comments?

1-800-579-8327

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

CVS Health™ Logo

NDC: 59779-365-01

Naphazoline HCl 0.025%

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

Allergy

Eye Drops

ANTIHISTAMINE &

REDNESS RELIEVER

RELIEVES REDNESS

& ITCHY EYES

STERILE

15 mL (0.5 FL OZ)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

CVS Health™ Logo Compare to the active

ingredient in Visine-A®*

NDC: 59779-365-01

Allergy

Eye Drops

Naphazoline HCl 0.025%

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

ANTIHISTAMINE &

REDNESS RELIEVER

RELIEVES REDNESS &

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: 59779-365
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: 59779-365-01	1 in 1 CARTON
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	01/25/2013

Labeler - CVS Pharmacy (062312574)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		063434679	PACK(59779-365) , LABEL(59779-365)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		155135783	MANUFACTURE(59779-365) , ANALYSIS(59779-365) , STERILIZE(59779-365)