VISINE A MULTI-ACTION EYE ALLERGY RELIEF- naphazoline hydrochloride and pheniramine maleate solution/ drops 
REMEDYREPACK INC.

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Visine®-A® MULTI-ACTION EYE ALLERGY Relief

Drug Facts

Active ingredientsPurpose
Naphazoline HCl 0.025%Redness reliever
Pheniramine maleate 0.3%Antihistamine

Use

Temporarily relieves itchy, red eyes due to:

  • pollen
  • ragweed
  • grass
  • animal hair and dander

Warnings

For external use only

Do not use if you are sensitive to any ingredient in this product

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • narrow angle glaucoma
  • trouble urinating due to an enlarged prostate gland

When using this product

  • pupils may become enlarged temporarily
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • overuse may cause more eye redness

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

Directions

  • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to four times a day
  • children under 6 years of age: consult 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, sodium hydroxide and/or hydrochloric acid

Questions?

call toll-free 888-734-7648 or 215-273-8755 (collect)

Caution

Do not use if VISINE ® imprinted neckband on bottle is broken or missing.

DRUG: Visine AMulti-Action Eye Allergy Relief Multi-Action Eye Allergy Relief

GENERIC: Naphazoline Hydrochloride and Pheniramine Maleate

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: OPHTHALMIC

NDC: 70518-0817-0

PACKAGING: 15 mL in 1 BOTTLE, DROPPER

ACTIVE INGREDIENT(S):

  • Naphazoline Hydrochloride 0.25mg in 1mL
  • Pheniramine Maleate 3mg in 1mL

INACTIVE INGREDIENT(S):

  • Boric Acid
  • Hydrochloric Acid
  • Sodium Hydroxide
  • Edetate Disodium
  • Benzalkonium Chloride
  • Sodium Borate
  • Water

Remedy_Label

VISINE A  MULTI-ACTION EYE ALLERGY RELIEF
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0817(NDC:42002-200)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.25 mg  in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0817-015 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/02/201705/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02048511/02/201705/06/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2020
Document Id: a4fad237-66ba-279a-e053-2995a90a6ed4
Set id: 9c52c855-adcc-4b72-9d7d-a5fb8cf06154
Version: 2
Effective Time: 20200506
 
REMEDYREPACK INC.