Dicyclomine Hydrochloride (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Dicyclomine Hydrochloride Injection, USP, 10 mg/mL in 2 mL single dose vials, (for INTRAMUSCULAR use only, NOT FOR INTRAVENOUS USE) is supplied as follows:

NDC 0641-6173-10: boxes of 10 vials

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

Protect from freezing.

For Product Inquiry call 1-877-845-0689.

17 PATIENT COUNSELING INFORMATION

17.1 Inadvertent Intravenous Administration

Dicyclomine injection is for intramuscular administration only. Do not administer by any other route. Inadvertent administration may result in thrombosis or thrombophlebitis, and injection site reactions 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 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 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 use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine 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 [see Warnings and Precautions (5.3)].

Manufactured by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922

Revised December 2019

462-718-02

PRINCIPAL DISPLAY PANEL

NDC 0641-6173 -01 Rx only
Dicyclomine
HCl Injection, USP
20 mg per 2 mL
(10 mg/mL)
IM use ONLY
Not for IV use2 mL Single Dose Vial

NDC 0641-6173 -10 Rx only
Dicyclomine
HCl Injection, USP
20 mg per 2 mL
(10 mg/mL)
For Intramuscular use ONLY
Not for Intravenous use10 x 2 mL Single Dose Vials

SERIALIZATION IMAGE

Layout 1

DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6173 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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0641-6173-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0641-6173-01) 1 NDC:0641-6173-01 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0641-6173-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040465 12/30/2015

Labeler — Hikma Pharmaceuticals USA Inc. (946499746)

Establishment
Name	Address	ID/FEI	Operations
Hikma Pharmaceuticals USA Inc.		946499746	analysis (0641-6173), label (0641-6173), manufacture (0641-6173), pack (0641-6173)

Revised: 12/2019 Hikma Pharmaceuticals USA Inc.