ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

Artificial Tears by

Drug Labeling and Warnings

Artificial Tears by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

Uses

• relieves dryness of the eye
• prevents further irritation

Warnings

• Do not use if solution changes color or becomes cloudy
• with contact lenses

When using this product  

• do not touch tip of container to any surface to avoid contamination
• replace cap after use

Stop use and ask a doctor if

• you experience eye pain, changes in vision, continued redness or irritation of the eye
• condition worsens or lasts for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• instill 1 to 2 drops in the affected eye(s) as needed.

Other information

• store at 15° - 30°C (59° - 86°F)
• keep tightly closed

 

Inactive ingredients

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

Questions or comments?

Call 1-800-645-2158

9 am - 5 pm ET, Monday-Friday.

Serious side effects associated with use of this product may be reported to this number

How Supplied

15 mL – 68788-9858-1

Rugby ®

Duluth, GA 30097

Relabeled By Preferred Pharmaceuticals, Inc.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-9858(NDC: 0536-1970)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	14 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-9858-1	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/13/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/13/2012

Labeler - Preferred Pharmaceuticals, Inc (791119022)

Registrant - Preferred Pharmaceuticals, Inc (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc		791119022	RELABEL(68788-9858)