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Naphazoline Hydrochloride and Pheniramine Maleate

Dosage form: solution/ drops
Ingredients: Naphazoline Hydrochloride 0.25mg in 1mL, Pheniramine Maleate 3mg in 1mL
Labeler: Akorn, Inc.
NDC Code: 17478-065

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

When using this product
  • pupils may become enlarged temporarily causing light sensitivity
  • 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
  • some users may experience a brief tingling sensation

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
  • 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?

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 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

► Relieves Redness

► Relieves itchy Eyes Due To:

Pollen ● Ragweed ● Grass

Animal Hair & Dander

Sterile

15 mL (0.5 fl. oz.)

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE 
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-065
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 Description
1NDC:17478-065-121 BOTTLE, DROPPER in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20279501/24/2013
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc063434679PACK(17478-065), LABEL(17478-065)
Establishment
NameAddressID/FEIOperations
Akorn, Inc. 155135783MANUFACTURE(17478-065), ANALYSIS(17478-065), STERILIZE(17478-065)

 
Akorn, Inc.

← See all Naphazoline Hydrochloride and Pheniramine Maleate brands

Medically reviewed on Oct 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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