Your browser does not support JavaScript! NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE SOLUTION/ DROPS [WALGREENS]
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NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE solution/ drops
[Walgreens]


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 lass 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 -800-579-8327

Principal Display Panel Text for Container Label:

Well at

Walgreens

NDC 0363-9650-02

STERILE

Allergy

Eye Drops

Naphazoline HCl 0.025% and

Pheniramine Maleate 0.3%

Ophthalmic Solution USP

Antihistamine & Redness Reliever

Relieves redness & itchy eyes

0.5 FL OZ (15 mL)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

Well at

Walgreens

NDC 0363-9650-02

WALGREENS PHARMACIST RECOMMENDED‡

NEW

STERILE

Allergy

Eye Drops

Naphazoline HCl 0.025% and

Pheniramine Maleate 0.3%

Ophthalmic Solution USP

Antihistamine & Redness Reliever

Relieves redness &

itchy eyes due to:

● Pollen

● Ragweed ● Grass

● Animal hair & dander

Compare to Visine-A® active ingredients#

0.5 FL OZ (15 mL)

Principal Display Panel Text for Carton Label
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE 
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-9650
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:0363-9650-021 in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20279504/23/2013
Labeler - Walgreens (008965063)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc063434679PACK(0363-9650), LABEL(0363-9650)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.155135783MANUFACTURE(0363-9650), ANALYSIS(0363-9650), STERILIZE(0363-9650)

Revised: 4/2013
 
Walgreens

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