Naphazoline Hydrochloride and Pheniramine Maleate

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Naphazoline Hydrochloride 0.025%

Pheniramine Maleate 0.3%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itchy, red eyes due to:

• pollen
• ragweed
• grass
• animal hair and dander

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use if you are sensitive to any ingredient in this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• heart disease
• high blood pressure
• narrow angle glaucoma
• trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens or lasts more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• some users may experience a brief tingling sensation
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-932-5676

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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:

• Pollen
• Ragweed ● Grass
• Animal hair & dander

Compare to Visine-A^® active ingredients#

0.5 FL OZ (15 mL)

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• Naphazoline Hydrochloride and Pheniramine Maleate
• Naphazoline Hydrochloride
• Naphazoline
• Pheniramine Maleate
• Pheniramine
• Boric Acid
• Sodium Borate
• Benzalkonium Chloride
• Edetate Disodium
• Sodium Hydroxide
• Hydrochloric Acid
• Water

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 446 matching rows.

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.