MULTI-ACTION RELIEF- polyvinyl alcohol, povidone and tetrahydrozoline hydrochloride solution/ drops

Multi-Action Relief by

Drug Labeling and Warnings

Multi-Action Relief by is a Otc medication manufactured, distributed, or labeled by Altaire Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Multi-Action Relief Drops
15mL
NDC: 59390-156-13

  

              

Drug Facts

Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Tetrahydrozoline hydrochloride 0.05%

Purpose

Lubricant

Lubricant

Redness Reliever

Uses

• for the temporary relief of burning and irritation due to dryness of the eye
  
• for use as a protectant against further irritation or to relieve dryness of the eye
  
• relieves redness of the eye due to minor eye irritations

Warnings

For use in the eye(s) only.

Do not use if

solution changes color or becomes cloudy.

Ask a doctor before use if you have

narrow angle glaucoma.

When using this product 

• to avoid contamination, do not touch tip of container to any surface
  
• replace cap after using 
  
• overuse may produce increased redness of the eye
  
• pupils may become enlarged temporarily

Stop use and ask a doctor if 

• you experience eye pain
  
• you experience changes in vision 
  
• you experience continued redness or irritation of the eye 
  
• the condition worsens 
  
• symptoms last 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 or 2 drops in the affected eye(s) up to four times daily.

Other Information 

• store at room temperature.
  
• remove contact lenses before using
  
• tamper evident: Do not use if imprinted neckband on bottle is torn, broken or missing.

Inactive ingredients 

benzalkonium chloride, dextrose, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate. Hydrochloric acid or sodium hydroxide may be added to adjust pH.

PRINCIPAL DISPLAY PANEL

Multi-Action
RELIEF DROPS
LUBRICANT/REDNESS
RELIEVER EYE DROPS
STERILE
0.5 FL OZ (15mL)

INGREDIENTS AND APPEARANCE

MULTI-ACTION RELIEF 
polyvinyl alcohol, povidone and tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59390-156
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	5 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	6 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	HYDROCHLORIC ACID (UNII: QTT17582CB)
May contain	SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59390-156-13	1 in 1 CARTON	05/09/2009
1		15 mL in 1 BOTTLE, DROPPER; 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	05/09/2009

Labeler - Altaire Pharmaceuticals Inc. (786790378)