EQUATE EYE ALLERGY RELIEF DROPS- naphazoline hydrochloride, pheniramine maleate solution/ drops

Equate Eye Allergy Relief Drops by

Drug Labeling and Warnings

Equate Eye Allergy Relief Drops by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Altaire Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Walmart

Equate

Eye Allergy Relief Drops 15mL

NDC 49035-874-13

Drug Facts

Active ingredients

Naphazoline HCl (0.027%)

Pheniramine Maleate(0.315%)

Purpose

Redness Reliever

Antihistamine

Uses

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

Warnings

Do not use

• if you are sensitive to any ingredient in this product.
  
• if this product changes color or becomes cloudy.

Ask a doctor before use if you have

• heart disease
  
• high blood pressure
  
• trouble urinating due to 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(s) 
  
• replace cap after using
  
• 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 persists for 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 of 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 room temperature 20°-25°C (68°-77°F).
  
• protect from light
  
• use before expiration date marked on carton or bottle

Inactive ingredients

benzalkonium chloride 0.01%, boric acid, edetate disodium 0.1%, hypromellose, purified water, sodium borate and sodium chloride.

Questions?

Call: 1 888- 287-1915

PRINCIPAL DISPLAY PANEL

NDC: 49035-874-13
equate
Eye Allergy
Relief Drops
Itching and Redness
Reliever Eye Drops

INGREDIENTS AND APPEARANCE

EQUATE EYE ALLERGY RELIEF DROPS 
naphazoline hydrochloride, pheniramine maleate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-874
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.27 mg  in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	3.15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-874-13	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/08/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078208	03/08/2018

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Altaire Pharmaceuticals, Inc. (786790378)