Naphcon A description, usages, side effects, indications, overdosage, supplying and lots more!

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Naphcon A

Alcon Laboratories, Inc.
Alcon Laboratories, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OTC - ACTIVE INGREDIENT SECTION

Naphazoline Hydrochloride 0.025%
Pheniramine Maleate 0.3%

OTC - PURPOSE SECTION

Redness reliever
Antihistamine

INDICATIONS & USAGE SECTION

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

  • ragweed
  • pollen
  • grass
  • animal dander and hair

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause redness of the eye(s)
  • remove contact lenses before using
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

OTC - STOP USE SECTION

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 last more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

See inside of carton for additional WARNINGS.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times every day
  • children under 6 years: ask a doctor

OTHER SAFETY INFORMATION

Other Information

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions?
In the U.S. call 1-800-757-9195

INDICATIONS & USAGE SECTION

Temporary relief of the minor eye symptoms of itching and redness caused by ragweed, pollen, grass, animal dander and hair.

DESCRIPTION SECTION

Active: Naphazoline Hydrochloride 0.025%. Pheniramine Maleate 0.3%. Preservative: Benzalkonium Chloride 0.01%. Inactive: Boric Acid, Edetate Disodium 0.01%, Purified Water, Sodium Borate, Sodium Chloride, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH). The sterile ophthalmic solution has a pH of about 6 and a tonicity of about 270 mOsm/Kg.

DIRECTIONS SECTION

Put 1 or 2 drops in the affected eye(s) up to 4 times every day.

WARNINGS SECTION

To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

If solution changes color or becomes clooudy, do not 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.

When using this product, pupils may become enlarged temporarily. Overuse may cause more redness of the eye(s).

If you are sensitive to any ingredient in this product, do not use. Do not use this product if you have heart disease, high blood pressure, narrow angle glaucoma or trouble urinating unless directed by a physician.

Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature. Before using in children under 6 years of age, consult your physician. Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Remove contact lenses before using.

Store at 20° - 25°C (68° - 77°F).

Protect from light.

Use before the expiration date marked on the carton or bottle.

ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA

PRINCIPAL DISPLAY PANEL

100% MORE FREE
30 mL at 15 mL price!

Previously by Prescription Only

Alcon®

NAPHCON A®
EYE DROPS

EYE ALLERGY RELIEF

Relieves Itching & Redness

STERILE   1 FL OZ (30 mL)

PRINCIPAL DISPLAY PANEL

RECOMMENDED by
EYE DOCTORS

Alcon®
NAPHCON A®
EYE DROPS

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE   0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL

POCKET SIZE

CONVENIENT TAKE ANYWHERE

NAPHCON A®
EYE DROPS

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE

Alcon®

Two 5 mL
(0.16 FL OZ) Bottles

PRINCIPAL DISPLAY PANEL

POCKET SIZE
CONVENIENT ● TAKE ANYWHERE

NAPHCON A®
EYE DROPS

Relieves Redness & Itching

EYE ALLERGY RELIEF

CLINICALLY PROVEN

Alcon®

STERILE
5 mL (0.16 FL OZ) Bottle

Naphcon A

naphazoline hydrochloride and pheniramine maleate SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0065-0085
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naphazoline hydrochloride Naphazoline 0.25 mg
PHENIRAMINE MALEATE Pheniramine 3 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
BORIC ACID
EDETATE DISODIUM
water
SODIUM BORATE
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE
2 30 in 1 BOTTLE
3 5 in 1 BOTTLE
4 5 in 1 BOTTLE
5 NDC:0065-0085-52 1 in 1 CARTON

Marketing Information

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


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