VISINE A MULTI-ACTION EYE ALLERGY RELIEF- naphazoline hydrochloride and pheniramine maleate solution/ drops

Visine A by

Drug Labeling and Warnings

Visine A by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Naphazoline HCl 0.025%	Redness reliever
Pheniramine maleate 0.3%	Antihistamine

Use

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 at 15° to 25°C (59° to 77°F)

Inactive ingredients

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

Questions?

call toll-free 888-734-7648 or 215-273-8755 (collect)

Caution

Do not use if VISINE ® imprinted neckband on bottle is broken or missing.

PRINCIPAL DISPLAY PANEL

DRUG: Visine AMulti-Action Eye Allergy Relief Multi-Action Eye Allergy Relief

GENERIC: Naphazoline Hydrochloride and Pheniramine Maleate

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: OPHTHALMIC

NDC: 70518-0817-0

PACKAGING: 15 mL in 1 BOTTLE, DROPPER

ACTIVE INGREDIENT(S):

• Naphazoline Hydrochloride 0.25mg in 1mL
• Pheniramine Maleate 3mg in 1mL

INACTIVE INGREDIENT(S):

• Boric Acid
• Hydrochloric Acid
• Sodium Hydroxide
• Edetate Disodium
• Benzalkonium Chloride
• Sodium Borate
• Water

INGREDIENTS AND APPEARANCE

VISINE A   MULTI-ACTION EYE ALLERGY RELIEF
naphazoline hydrochloride and pheniramine maleate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0817(NDC: 42002-200)
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: 70518-0817-0	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020485	11/02/2017

Labeler - REMEDYREPACK INC. (829572556)