Naphazoline Hydrochloride and Pheniramine Maleate description, usages, side effects, indications, overdosage, supplying and lots more!

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Naphazoline Hydrochloride and Pheniramine Maleate

Walgreens
Akorn, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 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)

Naphazoline Hydrochloride and Pheniramine Maleate

Naphazoline hydrochloride and Pheniramine Maleate SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-9650
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naphazoline hydrochloride Naphazoline 0.25 mg
PHENIRAMINE MALEATE Pheniramine 3 mg

Inactive Ingredients

Ingredient Name Strength
BORIC ACID
SODIUM BORATE
benzalkonium chloride
EDETATE DISODIUM
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, DROPPER
2 NDC:0363-9650-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202795 2013-04-23


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Be sure to consult your doctor before taking any medication!
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