Your browser does not support JavaScript! ASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]
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ASSURED ORIGINAL RELIEF EYE (tetrahydrozoline hydrochloride) solution
[GREENBRIER INTERNATIONAL, INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient                                                           Purpose

Tetrahydrozoline HCL 0.05%.........................................Redness reliever

Uses

  • for the relief of redness of the eyes due to minor eye irritations

Warnings

Ask a doctor before use if you have narrow angle glaucoma

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • to avoid contamination, do not touch tip
  • replace cap after each use

Stop use and ask a doctor if

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

Directions

  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor

Other information

  • some users may experience a brief tingling sensation
  • store at 15o to 25oC (59o to 77oF)

Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320


MADE IN KOREA

image of carton label

ASSURED ORIGINAL RELIEF EYE  
tetrahydrozoline hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-9376
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
EDETATE DISODIUM 
SODIUM CHLORIDE 
SODIUM BORATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-9376-51 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/28/2013
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

Revised: 2/2013
 
GREENBRIER INTERNATIONAL, INC.

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