NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE- naphazoline hydrochloride and pheniramine maleate solution/ drops 
Akorn, Inc.

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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 become 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?

Call toll-free 1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 17478-065-12

Naphazoline HCl 0.025%

and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

ANTIHISTAMINE & REDNESS

RELIEVER

Eye Allergy

Relief Eye Drops

Sterile

15 mL (0.5 fl. oz.)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 17478-065-12

Naphazoline HCl 0.025%

and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

ANTIHISTAMINE & REDNESS

RELIEVER

Eye Allergy

Relief Eye Drops

► Relives Redness

► Relieves itchy Eyes Due To:

Pollen ● Ragweed ● Grass

Animal Hair & Dander

Sterile

15 mL (0.5 fl. oz.)

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:17478-065
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:17478-065-12 1 in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202795 01/24/2013
Labeler - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc 063434679 PACK(17478-065) , LABEL(17478-065)
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc. 155135783 MANUFACTURE(17478-065) , ANALYSIS(17478-065) , STERILIZE(17478-065)

Revised: 1/2013
Document Id: d13209d6-46d4-41b7-9fc6-4c2bbc8882dd
Set id: 78c5250c-b27c-4b1d-a4b8-571973ac3ae4
Version: 1
Effective Time: 20130129
 
Akorn, Inc.