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 Alcon Laboratories, Inc., Alcon Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• 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

100% MORE FREE
30 mL at 15 mL price!

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE 30 mL (1 FL OZ)

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

ACTUAL SIZE

Combines an antihistamine and a redness reliever for the temporary relief of itchy, red eyes.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

©2002, 2009, 2014, 2015 Novartis

9011948-0615

Alcon®
a Novartis company

LOT:
EXP.:

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE 30 mL (1 FL OZ)

Alcon®

Active ingredients: Naphazoline hydrochloride 0.025%, Pheniramine maleate 0.3%.

Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.

DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily.
Children under 6 years: ask a doctor.

WARNINGS: See Drug Facts on outer carton for Warnings.

Keep this and all drugs out of the reach of children.

Remove contact lenses before using.

To avoid contamination, do not touch tip of container to any surface.

To open: push cap down while turning.
Replace cap after each use.

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

Store at 20° - 25°C (68° - 77°F).
Protect from light.

ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA
©2002, 2005, 2015 Novartis

LOT/EXP.:

H13948-0615

PRINCIPAL DISPLAY PANEL

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

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 not use if seal is damaged or missing at time of purchase.

Actual Size

Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

©2002, 2008, 2014, 2015 Novartis

9011949-0615

Alcon®
a Novartis company

LOT:
EXP.:

CLINICALLY PROVEN

EYE ALLERGY RELIEF

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 not use if seal is damaged or missing at time of purchase.

Actual Size

Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134 USA

Alcon

LOT:
EXP.:

9017142-0419

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE 15 mL (0.5 FL OZ)

Alcon®

Active ingredients: Naphazoline hydrochloride 0.025%, Pheniramine maleate 0.3%.

Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.

DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily.
Children under 6 years: ask a doctor.

WARNINGS: See Drug Facts on outer carton for Warnings.

Remove contact lenses before using.

To avoid contamination, do not touch tip of container to any surface.

To open: push cap down while turning.
Replace cap after each use.

Keep this and all drugs out of the reach of children.

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

Store at 20° - 25°C (68° - 77°F).
Protect from light.

ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA
©2002, 2005, 2015 Novartis

LOT/EXP.:

H13949-0615

EYE ALLERGY RELIEF

NAPHCON A®

Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%

Ophthalmic Solution

Redness Reliever and Antihistamine 

RELIEVES ITCHING & REDNESS

EYE DROPS

CLINICALLY PROVEN

STERILE 15 mL (0.5 FL OZ)

Alcon®

Active ingredients: Naphazoline EYE ALLERGY RELIEF Hydrochloride 0.025%, Pheniramine Maleate 0.3%.

Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.

DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily. Children under 6 years: ask a doctor.

WARNINGS: See Drug Facts on outer carton for Warnings. Remove contact lenses before using. To avoid contamination, do not touch tip of container to any surface.

To open: push cap down while turning. Replace cap after each use.

Keep this and all drugs out of reach of children.

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

Store at 20° - 25°C (68° - 77°F).
Protect from light.

ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA 

LOT/EXP.:

H15558-0419

PRINCIPAL DISPLAY PANEL

POCKET SIZE

CONVENIENT
TAKE ANYWHERE

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE Two 5 mL (0.16 FL OZ) Bottles

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

ACTUAL SIZE

Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

©2002, 2004 - 2005, 2007, 2012, 2014, 2015 Novartis

9011956-0815

Alcon®
a Novartis company

LOT:
EXP.:

Convenient Take Anywhere

EYE ALLERGY RELIEF

POCKET SIZE

NAPHCON A®

Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%

Ophthalmic Solution

Redness Reliever and Antihistamine

Relieves Itching & Redness

EYE DROPS

CLINICALLY PROVEN

STERILE Two 5 mL (0.17 FL OZ) Bottles

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

ACTUAL SIZE

Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.

ACTUAL FILL

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

ALCON
LOT:
EXP.:

9017143-0419

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

STERILE 5mL (0.16 FL OZ )

Alcon®

Active ingredients: Naphazoline hydrochloride 0.025%, Pheniramine maleate 0.3%.

Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.

DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily.
Children under 6 years: ask a doctor.

WARNINGS: See Drug Facts on outer carton for Warnings.

Keep this and all drugs out of the reach of children.

Remove contact lenses before using.

To avoid contamination, do not touch tip of container to any surface.

To open: push cap down while turning.
Replace cap after each use.

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

Store at 20° - 25°C (68° - 77°F).

Protect from light.

ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA
©2002, 2005, 2015 Novartis

LOT/EXP.:

H13950-0615

EYE ALLERGY RELIEF

NAPHCON A®

Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%

Ophthalmic Solution

Redness Reliever and Antihistamine

RELIEVES ITCHING & REDNESS

EYE DROPS

CLINICALLY PROVEN

STERILE 5mL (0.17 FL OZ )

Active ingredients: Naphazoline Hydrochloride 0.025%, Pheniramine Maleate 0.3%. 

Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.

DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily. Children under 6 years: ask a doctor.

WARNINGS: See Drug Facts on outer carton for Warnings. Remove contact lenses before using. To avoid contamination, do not touch tip of container to any surface. To open: push cap down while turning. Replace cap after each use. Keep this and all drugs out of reach of children.

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

Store at 20° - 25°C (68° - 77°F).

Protect from light.

ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA

LOT
EXP:

H15557-0419

PRINCIPAL DISPLAY PANEL

POCKET SIZE

CONVENIENT  TAKE ANYWHERE

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE 5 mL (0.16 FL OZ)

Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.

ACTUAL SIZE

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word "Alcon" around the neck. Do not use if seal is damaged or missing at time of purchase.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

©2002, 2004 - 2005, 2007, 2012 - 2015 Novartis

9011947-0615

Alcon®
a Novartis company

LOT:
EXP.:

CONVENIENT  TAKE ANYWHERE

EYE ALLERGY RELIEF

POCKET SIZE

NAPHCON A®

Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%

Ophthalmic Solution

Redness Reliever and Antihistamine

RELIEVES ITCHING & REDNESS

EYE DROPS

CLINICALLY PROVEN

STERILE 5 mL (0.17 FL OZ)

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

ACTUAL SIZE

Combines a redness reliever and an antihistamine for temporary relief of itchy, red eyes.

ACTUAL FILL

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

Alcon

LOT:
EXP.:

9017128-0419

INGREDIENTS AND APPEARANCE

NAPHCON A  
naphazoline hydrochloride and pheniramine maleate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0085
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)
Boric Acid (UNII: R57ZHV85D4)
Edetate Disodium (UNII: 7FLD91C86K)
Water (UNII: 059QF0KO0R)
Sodium Borate (UNII: 91MBZ8H3QO)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0085-15	1 in 1 CARTON	06/08/1994
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0065-0085-38	1 in 1 CARTON	06/08/1994	02/28/2019
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0065-0085-42	2 in 1 CARTON	06/08/1994
3		5 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0065-0085-52	1 in 1 CARTON	06/08/1994
4		5 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-0085)