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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Naphazoline Hydrochloride (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV), Pheniramine Maleate (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)
Available from:
Johnson & Johnson Consumer Inc.
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
Temporarily relieves itchy, red eyes due to: - pollen - ragweed - grass - animal hair and dander
Authorization status:
New Drug Application
Authorization number:
69968-0367-1, 69968-0367-2

VISINE ALLERGY EYE RELIEF MULTI-ACTION- naphazoline hydrochloride and

pheniramine maleate solution/ drops

Johnson & Johnson Consumer Inc.

----------

Visine® Allergy Eye Relief Multi-Action

Drug Facts

Active ingredients

Purpose

Naphazoline HCl 0.025%

Redness reliever

Pheniramine maleate 0.3%

Antihistamine

Us es

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 becomes 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 4 times a

children under 6 years of age: consult a doctor

Other information

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

Ques tions ?

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

Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

VISINE

NAPHAZOLINE HCl 0.025%

AND PHENIRAMINE MALEATE 0.3%

OPHTHALMIC SOLUTION

ANTIHISTAMINE AND REDNESS RELIEVER

ALLERGY EYE RELIEF

MULTI-ACTION

ORIGINAL

PRESCRIPTION STRENGTH

Clinically Proven to

Relieve Red,

Itchy Eyes

STERILE

EYE DROPS

1/2 FL OZ (15mL)

VISINE ALLERGY EYE RELIEF MULTI-ACTION

naphazoline hydrochloride and pheniramine maleate solution/ drops

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 36 7

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Johnson & Johnson Consumer Inc.

Na pha zo line Hydro chlo ride (UNII: MZ113178 7D) (NAPHAZOLINE - UNII:H231GF11BV)

Naphazo line Hydro chlo ride

0 .25 mg in 1 mL

Phenira mine Ma lea te (UNII: NYW9 0 56 55B) (PHENIRAMINE - UNII:134FM9 ZZ6 M)

Pheniramine Maleate

3 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Benza lko nium Chlo ride (UNII: F5UM2KM3W7)

Bo ric Acid (UNII: R57ZHV8 5D4)

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

Wa ter (UNII: 0 59 QF0 KO0 R)

So dium Bo ra te (UNII: 9 1MBZ8 H3QO)

So dium Hydro xide (UNII: 55X0 4QC32I)

Hydro chlo ric Acid (UNII: QTT1758 2CB)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 9 6 8 -

0 36 7-1

1 in 1 CARTON

0 5/0 6 /20 19

1

15 mL in 1 BOTTLE; Type 4: Device Co ated/Impregnated/Otherwise

Co mbined with Drug

2

NDC:6 9 9 6 8 -

0 36 7-2

2 in 1 CARTON

0 6 /0 3/20 19

2

15 mL in 1 BOTTLE; Type 4: Device Co ated/Impregnated/Otherwise

Co mbined with Drug

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 20 48 5

0 5/0 6 /20 19

Labeler -

Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2019

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