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Naphcon A Prescribing Information

Package insert / product label
Generic name: naphazoline hydrochloride and pheniramine maleate
Dosage form: eye drops
Drug class: Ophthalmic antihistamines and decongestants

Medically reviewed by Drugs.com. Last updated on Dec 13, 2023.

Active ingredientsPurpose
Naphazoline hydrochloride 0.025%Redness reliever
Pheniramine maleate 0.3%Antihistamine

Indications and Usage for Naphcon A

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.

Naphcon A Dosage and Administration

  • 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 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.

SEE COUPON INSIDE

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

Alcon

LOT:
EXP.:

300055595-0122

15 mL Outer Carton

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
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:

300035727-0320

15 mL Container

PRINCIPAL DISPLAY PANEL

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

2x5 mL Outer Container

PRINCIPAL DISPLAY PANEL

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:


300035726-0320

5 mL Label
NAPHCON A
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0085
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride0.25 mg in 1 mL
Pheniramine Maleate (UNII: NYW905655B) (Pheniramine - UNII:134FM9ZZ6M) Pheniramine Maleate3 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-0085-151 in 1 CARTON01/03/1995
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0065-0085-381 in 1 CARTON06/08/199402/28/2019
230 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0065-0085-422 in 1 CARTON01/07/200503/31/2024
35 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0065-0085-521 in 1 CARTON06/08/199411/30/2021
45 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02022606/08/1994
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research LLC007672236manufacture(0065-0085)

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