Dicyclomine Hydrochloride (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 68151-1161

NDC: 68151-1161-1 1 mL in a SYRINGE, PLASTIC

17 PATIENT COUNSELING INFORMATION

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 human milk feeding 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)].

Distributed by:

Par Pharmaceutical

Chestnut Ridge, NY 10977

Code 1214A00

Rev. 06/17

DICYCLOMINE HYDROCHLORIDE SOLUTION

Label Image
(click image for full-size original)
DICYCLOMINE HYDROCHLORIDE
dicyclomine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-1161(NDC:0603-1161)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GLYCERIN
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
SORBITOL
SUCROSE
WATER
Product Characteristics
Color pink Score
Shape Size
Flavor FRUIT PUNCH Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-1161-1 1 mL in 1 SYRINGE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040169 06/23/2005
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-1161)

Revised: 12/2017 Carilion Materials Management

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.