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

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 of container to any surface
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

top open bottle, push cap down and twist counterclockwise. To close bottle, twist clockwise until it stops turning.
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 description
MAJOR REDNESS RELIEVER EYE 
tetrahydrozoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6334
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6334-351 in 1 CARTON11/25/201408/31/2020
115 mg in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/25/201408/31/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020
 
Major Pharmaceuticals