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
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Labeler — Pharmasource Meds, LLC (118772692) |
Revised: 03/2023 Pharmasource Meds, LLC
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