Dicyclomine Hydrochloride (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Dicyclomine Hydrochloride Injection, USP is supplied as:

Product Code	Unit of Sale	Strength	Each
842102	NDC 63323-842-02 Packaged in carton of 5	20 mg per 2 mL (10 mg per mL)	NDC 63323-842-21 2 mL Single-Dose Vial

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

Protect from freezing.

17 PATIENT COUNSELING INFORMATION

17.1 Inadvertent Intravenous Administration

Dicyclomine Hydrochloride Injection is for intramuscular administration only. Do not administer by any other route. Inadvertent administration may result in thrombosis or thrombophlebitis, and injection site such as pain, edema, skin color change and even reflex sympathetic dystrophy syndrome [see Adverse Reactions ( 6.2)] .

17.2 Use in Infants

Inform parents and caregivers not to administer dicyclomine hydrochloride in infants less than 6 months of age [see Use in Specific Populations ( 8.4)] .

17.3 Use in Nursing Mothers

Advise lactating women that dicyclomine hydrochloride should not be used while breastfeeding their infants [see Use in Specific Populations (8.3, 8.4)].

17.4 Peripheral and Central Nervous System

In the presence of a high environmental temperature, heat prostration can occur with dicyclomine hydrochloride use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine hydrochloride may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking dicyclomine hydrochloride [see Warnings and Precautions (5.3)].

Manufactured for:

www.fresenius-kabi.com/us
Made in India

451546

Issued: May 2019

PACKAGE LABEL — PRINCIPAL DISPLAY — Dicyclomine Hydrochloride 20 mg Vial Label
NDC 63323-842-21
Dicyclomine Hydrochloride Injection, USP
20 mg per 2 mL (10 mg per mL)
For Intramuscular Use Only
2 mL Single-Dose Vial Rx only

PACKAGE LABEL — PRINCIPAL DISPLAY — Dicyclomine Hydrochloride 20 mg Vial Carton Panel
NDC 63323-842-02 842102
Dicyclomine Hydrochloride Injection, USP
20 mg per 2 mL (10 mg per mL)
For Intramuscular Use Only
5 x 2 mL Single-Dose Vials Rx only

DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-842 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER SODIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63323-842-02 5 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (63323-842-21) 1 NDC:63323-842-21 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (63323-842-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210257 09/12/2019

Labeler — Fresenius Kabi USA, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
Caplin Steriles Limited		650744670	analysis (63323-842), manufacture (63323-842), pack (63323-842)

Revised: 07/2019 Fresenius Kabi USA, LLC