ALLERGY EYE DROPS- naphazoline hydrochloride and pheniramine maleate solution/ drops 
Chain Drug Consortium

----------

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:

NDC 68016-450-00

Premier

Value® Logo

Allergy

Eye Drops

ANTIHISTAMINE &

REDNESS RELIEVER

Naphazoline HCl 0.025% and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

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:

NDC 68016-450-00

*COMPARE TO THE

ACTIVE INGREDIENT

IN VISINE-A®

Premier

Value® Logo

Allergy

Eye Drops

ANTIHISTAMINE &

REDNESS RELIEVER

Naphazoline HCl 0.025% and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

RELIEVES REDNESS &

ITCHY EYES DUE TO:

  • Pollen
  • Ragweed
  • Grass
  • Animal hair & dander

15 mL (0.5 FL OZ)

STERILE PV Brand Logo

Principal Display Panel Text for Carton Label
ALLERGY EYE DROPS 
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-450
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-450-001 in 1 CARTON01/10/201401/31/2017
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20279501/10/201401/31/2017
Labeler - Chain Drug Consortium (101668460)

Revised: 10/2020
Document Id: 748afe52-0b29-4177-8a26-d12641f03efe
Set id: 57e4f554-a0c5-46e1-8b19-dd6559b25c9f
Version: 4
Effective Time: 20201021
 
Chain Drug Consortium