MAJOR REDNESS RELIEVER EYE- tetrahydrozoline hydrochloride solution/ drops

Major Redness Reliever Eye by

Drug Labeling and Warnings

Major Redness Reliever Eye by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                               Purpose

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

PURPOSE

Uses

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

WARNINGS

Warnings

Ask a doctor before use if you have narrow angle glaucoma

WHEN USING

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

ASK DOCTOR

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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

STORAGE AND HANDLING

Other information

• some users may experience a brief tingling sensation
• store at 15° to 25°C (59° to 77°F)
  

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

Distributed By:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAJOR REDNESS RELIEVER EYE 
tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6334
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6334-35	1 in 1 CARTON	11/25/2014	08/31/2020
1		15 mg in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/25/2014	08/31/2020

Labeler - Major Pharmaceuticals (191427277)