NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE- naphazoline hydrochloride and pheniramine maleate solution/ drops 
Walgreens

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Drug Facts

Active ingredients

Naphazoline Hydrochloride 0.025%

Pheniramine Maleate 0.3%

Purpose

Redness reliever

Antihistamine

Uses

Temporarily relieves itchy, red eyes due to:

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

Other information

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:

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‡

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:

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 Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9650
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride 0.25 mg  in 1 mL
Pheniramine Maleate (UNII: NYW905655B) (Pheniramine - UNII:134FM9ZZ6M) Pheniramine Maleate 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Boric Acid (UNII: R57ZHV85D4)  
Sodium Borate (UNII: 91MBZ8H3QO)  
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Hydrochloric Acid (UNII: QTT17582CB)  
Water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-9650-02 1 in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202795 04/23/2013
Labeler - Walgreens (008965063)
Registrant - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc 063434679 PACK(0363-9650) , LABEL(0363-9650)
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc. 155135783 MANUFACTURE(0363-9650) , ANALYSIS(0363-9650) , STERILIZE(0363-9650)

Revised: 4/2013
Document Id: fa931256-b009-4c7b-a376-0dc95b7207bc
Set id: 2f0592a4-af44-464b-8d08-7727c2fc1ca8
Version: 2
Effective Time: 20130423
 
Walgreens