NAPHCON A- naphazoline hydrochloride and pheniramine maleate solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV), Pheniramine Maleate (UNII: NYW905655B) (Pheniramine - UNII:134FM9ZZ6M)

Available from:

Alcon Laboratories, Inc.

INN (International Name):

Naphazoline Hydrochloride

Composition:

Naphazoline Hydrochloride 0.25 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

for the temporary relief of redness and itching of the eye(s) due to: - ragweed - pollen - grass - animal dander and hair - if you are sensitive to any ingredient in this product - if this solution changes color or becomes cloudy - narrow angle glaucoma - heart disease - high blood pressure - trouble urinating - you feel eye pain - changes in vision occur - redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Authorization status:

New Drug Application

Summary of Product characteristics

NAPHCON A - NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
SOLUTION/
DROPS
ALCON LABORATORIES, INC.
----------
DRUG FACTS
_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
PRINCIPAL DISPLAY PANEL
$3 COUPON INSIDE
NAPHCON A
Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%
Ophthalmic Solution
Redness Reliever and Antihistamine
RELIEVES ITCHING & REDNESS
EYE DROPS
®
STERILE 15 mL (0.5 FL OZ)
TAMPER EVIDENT: For your protection, this bottle has a seal imprinted
with the word
“Alcon” around the neck. Do