NAPHCON A- naphazoline hydrochloride and pheniramine maleate solution/ drops

Naphcon A by

Drug Labeling and Warnings

Naphcon A by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Naphazoline hydrochloride 0.025%: Redness reliever
• Pheniramine maleate 0.3%: Antihistamine

Uses

for the temporary relief of redness and itching of the eye(s) due to:

• ragweed
• pollen
• grass
• animal dander and hair

Warnings

For external use only

Do not use

• if you are sensitive to any ingredient in this product
• if this solution changes color or becomes cloudy

Ask a doctor before use if you have

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

When using this product

• pupils may become enlarged temporarily causing light sensitivity
• overuse may cause more eye redness
• remove contact lenses before using
• to avoid contamination, do not touch tip of container to any surface
• replace cap after each use

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Keep out of the 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 and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily
• children under 6 years: ask a doctor

Other information

• store at 20°-25°C (68°-77°F)
• protect from light

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

Questions?

In the U.S. call 1-800-757-9195 or visit www.alcon.com

HOW SUPPLIED

Product: 50090-0185

NDC: 50090-0185-0 15 mL in a BOTTLE / 1 in a CARTON

naphazoline hydrochloride and pheniramine maleate

INGREDIENTS AND APPEARANCE

NAPHCON A  
naphazoline hydrochloride and pheniramine maleate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-0185(NDC:0065-0085)
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
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Boric Acid (UNII: R57ZHV85D4)
Edetate Disodium (UNII: 7FLD91C86K)
Water (UNII: 059QF0KO0R)
Sodium Borate (UNII: 91MBZ8H3QO)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-0185-0	1 in 1 CARTON	11/28/2014
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020226	06/08/1994

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-0185)