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Advanced Relief Eye Drops

Generic Name: tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400 and povidone liquid
Dosage Form: ophthalmic liquid

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.

Drug Facts

Active Ingredient

Dextran 70 0.1%

Polyethylene Glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.5%

Purpose

Lubricant

Lubricant

Lubricant

Redness reliever

Use

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

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 become 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 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

  • store between 15° to 25°C (59°F to 77°F)


Inactive ingredients

boric acid, sodium borate, edetate disodium, benzalkonium chloride, sodium chloride, dilite hydrochloric acid, sterile purified water

package label

Advance relief

ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51134-0064
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg  in 1 mL
DEXTRAN 70 (DEXTRAN 70) DEXTRAN 70 1 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 400 10 mg  in 1 mL
POVIDONE (POVIDONE) POVIDONE 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID  
SODIUM BORATE  
EDETATE DISODIUM  
BENZALKONIUM CHLORIDE  
SODIUM CHLORIDE  
WATER  
Packaging
# Item Code Package Description
1 NDC:51134-0064-5 1 BOTTLE (BOTTLE) in 1 BOX
1 15 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 08/29/2010
Labeler - Samchundang Pharm. Co., Ltd. (687792325)
Registrant - Samchundang Pharm. Co., Ltd. (687792325)
Establishment
Name Address ID/FEI Operations
Samchundang Pharm. Co., Ltd. 687792325 manufacture
Revised: 08/2010
 
Samchundang Pharm. Co., Ltd.



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