GLYRX-PF (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

GLYRX-PF (glycopyrrolate injection), 0.2 mg/mL, is available in:

1 mL single-dose (0.2 mg/mL) vials packaged in 25s (NDC 51754-6000-4)

2 mL single-dose (0.4 mg/2 mL) vials packaged in 25s (NDC 51754-6001-4)

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Drowsiness or Blurred Vision: Inform patients that GLYRX-PF may cause drowsiness or blurred vision. Warn patients not to operate a motor vehicle or other machinery or perform hazardous work until these issues resolve [see Warnings and Precautions (5.2)].

Heat Prostration: Inform patients that in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents, including GLYRX-PF (due to decreased sweating), particularly in children and the elderly. Advise patients to avoid exertion and high environmental temperature after receiving GLYRX-PF [see Warnings and Precautions (5.3)].

Light Sensitivity: Advise patients that glycopyrrolate injection may cause sensitivity of the eyes to light and to protect their eyes from light after receiving GLYRX-PF [see Warnings and Precautions (5.9)].

Drug Interactions: Inform patients that GLYRX-PF may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication [see Drug Interactions (7) ].

Manufactured by:

Exela logo
(click image for full-size original)

Exela Pharma Sciences, LLC

Lenoir, NC 28645

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-1 mL Vial Label

1 mL vial
(click image for full-size original)

Rx Only NDC 51754-6000-1

GLYRX-PF

Glycopyrrolate Injection

0.2 mg/mL

For Intravenous or Intramuscular Use

1 mL Single Dose Vial

Discard Unused Portion

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 1 mL Carton

1 ml carton
(click image for full-size original)

Rx Only NDC 51754-6000-4

GLYRX-PF

Glycopyrrolate Injection

0.2 mg/mL

For Intravenous or Intramuscular Use

25 x 1 mL Single Dose Vials

Discard Unused Portion

Exela Pharma Sciences, LLC

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-2 mL Vial Label

2 ml vial
(click image for full-size original)

Rx Only NDC 51754-6001-1

GLYRX-PF

Glycopyrrolate Injection

0.4 mg/2 mL (0.2 mg/mL)

For Intravenous or Intramuscular Use

2 mL Single Dose Vial

Discard Unused Portion

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 2 mL Carton

2 ml carton
(click image for full-size original)

Rx Only NDC 51754-6001-4

GLYRX-PF

Glycopyrrolate Injection

0.4 mg/2 mL

For Intravenous or Intramuscular Use

25 x 2 mL Single Dose Vials

Discard Unused Portion

Exela Pharma Sciences, LLC

GLYRX-PF
glycopyrrolate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-6000
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-6000-4 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (51754-6000-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210997 07/02/2018
GLYRX-PF
glycopyrrolate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-6001
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-6001-4 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (51754-6001-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210997 07/02/2018
Labeler — Exela Pharma Sciences, LLC (831274399)
Establishment
Name Address ID/FEI Operations
Exela Pharma Sciences, LLC 831274399 MANUFACTURE (51754-6000), MANUFACTURE (51754-6001), LABEL (51754-6000), LABEL (51754-6001), ANALYSIS (51754-6000), ANALYSIS (51754-6001)

Revised: 08/2018 Exela Pharma Sciences, LLC

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