MAJOR REDNESS RELIEVER EYE - tetrahydrozoline hydrochloride solution/ drops 
Major Pharmaceuticals

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.

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Active ingredient                                                                               Purpose

Tetrahydrozoline Hydrochloride 0.05%....................................Redness reliever

Uses

  • Relieves redness of the eyes due to minor eye irritations

Warnings for external use only

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
  • do not touch tip of container to any surface to avoid contamination
  • 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 last more than 72 hours

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

Keep out of the 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 15° to 25°C (59° to 77°F)

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

Distributed By:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Made in Korea

image of carton label

MAJOR REDNESS RELIEVER EYE 
tetrahydrozoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6334
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
EDETATE DISODIUM 
WATER 
SODIUM BORATE 
SODIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:0904-6334-351 in 1 CARTON
115 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/30/2013
Labeler - Major Pharmaceuticals (191427277)

Revised: 06/2013
Document Id: 1f3cdf2f-d8e4-42f8-81ac-cb83c34e25d1
Set id: b3067b15-7863-458b-9097-3d2410c9b43f
Version: 1
Effective Time: 20130630
 
Major Pharmaceuticals