Dicyclomine (Page 5 of 5)

14 CLINICAL STUDIES

In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).

16 HOW SUPPLIED/STORAGE AND HANDLING

Dicyclomine hydrochloride tablets, USP 20 mg are supplied as Blue, Round, Unscored Tablet; Debossed “WW 27” and are available in:

Bottles of 60 tablets NDC 82982-029-60

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

To prevent fading, avoid exposure to direct sunlight.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

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 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)].

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

C50000477/01

Revised November 2021

PRINCIPAL DISPLAY PANEL

NDC: 82982-029-60
Dicyclomine USP
Tablets
20 mg
Rx only
60 Tablets
Pharmasource Meds, LLC

dicyclomine label
(click image for full-size original)
DICYCLOMINE
dicyclomine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82982-029(NDC:0143-1227)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
FD&C BLUE NO. 1
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color blue (BLUE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code WW;27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82982-029-60 60 TABLET in 1 BOTTLE None
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040161 03/14/2023
Labeler — Pharmasource Meds, LLC (118772692)

Revised: 03/2023 Pharmasource Meds, LLC

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