Eye Allergy Relief

pheniramine maleate and naphazoline hydrochloride

Dosage Form: ophthalmic solution
Drug Facts

Active ingredients

*Naphazoline HCl (0.02675%)

**Pheniramine Maleate (0.315%)

Purpose

*Redness Reliever

**Antihistamine

Uses

• Temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use

• if you are sensitive to any ingredient in this product


• if solution changes color or becomes cloudy

Ask a doctor before use if you have

• heart disease


• high blood pressure


• trouble urinating due to an enlarged prostate gland


• narrow angle glaucoma

When using this product

• overuse may cause more eye redness


• pupils may become enlarged temporarily


• do not touch tip of container to any surface


• to avoid contamination


• you may feel a brief tingling after putting drops in eye


• replace cap after use


• remove contact lenses before using

Stop use and ask a doctor if you experience

• eye pain


• changes in vision


• redness or irritation of the eye that 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 oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

Directions

• Adults and children 6 years of age and older: Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.


• Children under 6 years: Ask a doctor

Other information

• Store at 20°-25° C (68°-77° F).


• Protect from light.


• Use before expiration date marked on the carton or bottle.

Inactive ingredients

Benzalkonium Chloride, Boric Acid, Edetate Disodium, Hypromellose, Purified Water, Sodium Borate and Sodium Chloride.

Questions?

Call 1-800-910-6874

Package/Label Principal Display Panel

NDC 11673-430-15

eye drops allergy relief

itching and redness reliever

eye drops

pheniramine maleate 0.315% and naphazoline hydrochloride 0.02675% ophthalmic solution

[icon- arrow- up&up] sterile

0.5 FL OZ (15 mL)

Eye Allergy Relief  pheniramine maleate and naphazoline hydrochloride  solution/ drops

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-430 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.2675 mg  in 1 mL PHENIRAMINE MALEATE (PHENIRAMINE) PHENIRAMINE MALEATE 3.15 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   BORIC ACID   EDETATE SODIUM   HYPROMELLOSE   WATER   SODIUM BORATE   SODIUM CHLORIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11673-430-15 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 15 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (11673-430-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020065	08/31/2010

Labeler - Target Corporation (006961700)

Registrant - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		114406598	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Loba Feinchemie AG		300137478	API MANUFACTURE

Revised: 08/2010Target Corporation

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