OPCON-A- naphazoline hydrochloride and pheniramine maleate solution/ drops 
REMEDYREPACK INC.

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Drug Facts

Active ingredients

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Purpose

Redness reliever

Antihistamine

Uses

  • temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use

  • if you are sensitive to any ingredient in this product
  • if solution changes color or becomes cloudy

Ask a doctor before use if you have

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

When using this product

  • overuse may cause more eye redness
  • pupils may become enlarged temporarily
  • do not touch tip of container to any surface to avoid contamination
  • you may feel a brief tingling after putting drops in eye
  • replace cap after use
  • remove contact lenses before using

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • redness or irritation of the eye that 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 oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

Directions

  • Adults and children 6 years of age and older: Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
  • Children under 6 years: ask a doctor

Other information

  • store at 20°-25°C (68°-77°F)
  • protect from light
  • use before expiration date marked on the carton or bottle

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, hypromellose, purified water, sodium borate, sodium chloride. Hydrochloric acid may be used to adjust pH.

Questions or Comments?

Call: 1-800-553-5340

3976101

AB55211

®/™ are trademarks of Bausch & Lomb

Incorporated or its affiliates.

©Bausch & Lomb Incorporated

Distributed by: Bausch + Lomb, a Division

of Valeant Pharmaceuticals North

America LLC, Bridgewater, NJ 08807

DRUG: Opcon-A

GENERIC: Naphazoline hydrochloride and Pheniramine maleate

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: OPHTHALMIC

NDC: 70518-0475-0

PACKAGING: 15 mL in 1 BOTTLE, DROPPER

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • NAPHAZOLINE HYDROCHLORIDE 0.2675mg in 1mL
  • PHENIRAMINE MALEATE 3.15mg in 1mL

INACTIVE INGREDIENT(S):

  • BENZALKONIUM CHLORIDE
  • SODIUM BORATE
  • SODIUM CHLORIDE
  • WATER
  • BORIC ACID
  • EDETATE DISODIUM
  • HYDROCHLORIC ACID
  • HYPROMELLOSES

Remedy_Label

OPCON-A 
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0475(NDC:24208-430)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.2675 mg  in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE3.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0475-01 in 1 CARTON11/22/201704/06/2020
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006511/22/201704/06/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 4/2020
Document Id: a2a9258d-2e78-70e6-e053-2a95a90ad46b
Set id: 78686984-e9df-45fe-b86e-806c334970a9
Version: 4
Effective Time: 20200406
 
REMEDYREPACK INC.