Label: NAPHCON A- naphazoline hydrochloride and pheniramine maleate solution/ drops

  • NDC Code(s): 0065-0085-15, 0065-0085-38, 0065-0085-42, 0065-0085-52
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 16, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    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

    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.:

    15 mL Carton

    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

    15 mL Outer Carton

    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

    15 mL Container

    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

    15 mL Intermediate 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

    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

    5 mL Intermediate
  • 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 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

    5 mL Outer Carton
  • INGREDIENTS AND APPEARANCE
    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 CARTON06/08/1994
    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 CARTON06/08/1994
    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)