Opcon-A by REMEDYREPACK INC. Drug Facts

Drug Details [pdf]

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0475(NDC: 24208-430)
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.2675 mg in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	3.15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70518-0475-0	1 in 1 CARTON	11/22/2017	04/06/2020
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020065	11/22/2017	04/06/2020

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.