NAPHCON A- naphazoline hydrochloride and pheniramine maleate solution/ drops 
REMEDYREPACK INC.

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Drug Facts

OTC - ACTIVE INGREDIENT

Naphazoline Hydrochloride 0.025%
Pheniramine Maleate 0.3%

 

OTC - PURPOSE

Redness reliever
Antihistamine

 

INDICATIONS & USAGE

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

  • ragweed
  • pollen
  • grass
  • animal dander and hair

 

WARNINGS

 

OTC - DO NOT USE

Do not use

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

 

OTC - ASK DOCTOR

Ask a doctor before use if you have

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

 

OTC - WHEN USING

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

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

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

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

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

 

OTC - QUESTIONS

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

 

INDICATIONS & USAGE

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

 

DESCRIPTION

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.

 

DOSAGE & ADMINISTRATION

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

 

WARNINGS

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

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Naphcon A


GENERIC: naphazoline hydrochloride and pheniramine maleate


DOSAGE: SOLUTION/ DROPS


ADMINSTRATION: OPHTHALMIC


NDC: 52125-558-15


ACTIVE INGREDIENT(S):

  • Naphazoline Hydrochloride 0.25mg in 1mL
  • Pheniramine Maleate 3mg in 1mL


INACTIVE INGREDIENT(S):

  • Benzalkonium Chloride
  • Sodium Chloride
  • Sodium Borate
  • Sodium Hydroxide
  • Boric Acid
  • Edetate Disodium
  • Hydrochloric Acid
  • Water


PACKAGING: 15 mL in 1 BOTTLE




MM1

MM2

NAPHCON A 
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52125-558(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)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52125-558-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/201402/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02022612/15/201402/15/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2017
 
REMEDYREPACK INC.