Your browser does not support JavaScript! ALLERGY EYE DROPS (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [CVS PHARMACY]
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ALLERGY EYE DROPS (naphazoline hydrochloride and pheniramine maleate) solution/ drops
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Drug Facts

Active ingredients

Naphazoline Hydrochloride 0.025%

Pheniramine Maleate 0.3%

Purpose

Redness reliever

Antihistamine

Uses

Temporarily relieves itchy, red eyes due to:

  • pollen
  • ragweed
  • grass
  • animal hair and dander

Warnings

For external use only

Do not use if you are sensitive to any ingredient in this product

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • narrow angle glaucoma
  • trouble urinating due to an enlarged prostate gland

When using this product

  • pupils may become enlarged temporarily
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • overuse may cause more eye redness

Stop use and ask a doctor If

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

Keep out of 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 of age and over: put 1 or 2 drops in the affected eye(s) up to four times a day
  • children under 6 years of age: consult a doctor

Other information

  • some users may experience a brief tingling sensation
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Boric Acid and Sodium Borate buffer system preserved with Benzalkonium Chloride (0.01%) and Edetate Disodium (0.1%), Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Water for injection.

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

CVS

Pharmacy™

NDC 59779-366-01

Naphazoline HCl 0.025% and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

ALLERGY

EYE DROPS

ANTIHISTAMINE &

REDNESS RELIEVER

RELIEVES REDNESS &

ITCHY EYES

15 mL (0.5 FL OZ)

STERILE

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

CVS

Pharmacy™

NDC 59779-366-01

Compared to the

active ingredient

in Visine-A®*

NEW!

Naphazoline HCl 0.025% and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

ALLERGY

EYE DROPS

ANTIHISTAMINE &

REDNESS RELIEVER

RELIEVES REDNESS &

ITCHY EYES DUE TO:

● Pollen

● Ragweed

●Animal hair & dander

15 mL (0.5 FL OZ) STERILE

Principal Display Panel Text for Carton Label
ALLERGY EYE DROPS 
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-366
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naphazoline Hydrochloride (Naphazoline) Naphazoline Hydrochloride0.25 mg  in 1 mL
Pheniramine Maleate (Pheniramine) Pheniramine Maleate3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Boric Acid 
Sodium Borate 
Benzalkonium Chloride 
Edetate Disodium 
Sodium Hydroxide 
Hydrochloric Acid 
Water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-366-011 in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20279501/25/2013
Labeler - CVS Pharmacy (062312574)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc063434679PACK(59779-366), LABEL(59779-366)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc. 155135783MANUFACTURE(59779-366), ANALYSIS(59779-366), STERILIZE(59779-366)

Revised: 5/2013
 
CVS Pharmacy

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