Betaxolol Hydrochloride (Page 3 of 3)

DOSAGE AND ADMINISTRATION

The recommended dose is one to two drops of Betaxolol Hydrochloride Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to Betaxolol Hydrochloride Ophthalmic Solution may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised.

If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine and/or carbonic anhydrase inhibitors can be instituted.

HOW SUPPLIED

Betaxolol Hydrochloride Ophthalmic Solution is a sterile, isotonic, aqueous solution of betaxolol hydrochloride. Supplied as follows: 5, 10 and 15 mL in plastic ophthalmic DROP-TAINER* dispensers.

5 mL: NDC 61314-245-01 15 mL: NDC 61314-245-02

10 mL: NDC 61314-245-03

STORAGE: Store at room temperature.

Rx Only

*DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.

9001563-0306

Dist. by:

FALCON Pharmaceuticals, Ltd.

Fort Worth, Texas 76134

Mfd. by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Printed in USA

PRINCIPAL DISPLAY PANEL

NDC 61314-4245-03 Rx Only

FALCON Pharmaceuticals®

Betaxolol HCl

Ophthalmic

Solution,

0.5% as base

0.5%

10 mL Sterile

AFFILATE OF QUALITY RX

ALCON

LABORATORIES, INC.


carton
(click image for full-size original)

label
(click image for full-size original)
BETAXOLOL HYDROCHLORIDE
betaxolol hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-245
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAXOLOL HYDROCHLORIDE (BETAXOLOL) BETAXOLOL HYDROCHLORIDE 5.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
SODIUM CHLORIDE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61314-245-01 5 mL in 1 BOTTLE, PLASTIC None
2 NDC:61314-245-03 10 mL in 1 BOTTLE, PLASTIC None
3 NDC:61314-245-02 15 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA019270 05/15/2000
Labeler — Falcon Pharmaceuticals, Ltd. (874345820)
Registrant — Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Laboratories, Inc. 008018525 MANUFACTURE

Revised: 07/2011 Falcon Pharmaceuticals, Ltd.

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