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 H.J. Harkins Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 DOCTOR

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

WHEN USING

• 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

• 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 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.

DOSAGE & ADMINISTRATION

• 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

INACTIVE INGREDIENT

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

INDICATIONS & USAGE

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

• ragweed
• pollen
• grass
• animal dander and hair

PURPOSE

• Redness Reliever and Antihistamine Eye Drops
• Relieves Itching & Redness
• EYE ALLERGY RELIEF
  

ACTIVE INGREDIENT

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAPHCON A 
naphazoline hydrochloride and pheniramine maleate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52959-107
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)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52959-107-03	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020226	01/26/2016

Labeler - H.J. Harkins Company, Inc. (147681894)

Establishment
Name	Address	ID/FEI	Business Operations
H.J. Harkins Company, Inc.		147681894	relabel(52959-107) , repack(52959-107) , manufacture(52959-107)