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Artificial Tears by Preferred Pharmaceuticals, Inc

Medically reviewed on Mar 6, 2018

Dosage form: solution/ drops
Ingredients: POLYVINYL ALCOHOL, UNSPECIFIED 14mg in 1mL
Labeler: Preferred Pharmaceuticals, Inc
NDC Code: 68788-9858

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Artificial Tears Solution Drug Facts

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
ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9858(NDC:0536-1970)
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL, UNSPECIFIED14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
EDETATE DISODIUM 
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 
SODIUM CHLORIDE 
WATER 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:68788-9858-115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/13/2012
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Registrant - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9858)

 
Preferred Pharmaceuticals, Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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