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).
Dicyclomine hydrochloride tablets, USP 20 mg are supplied as Blue, Round, Unscored Tablet; Debossed “WW 27” and are available in:
Bottles of 20 tablets NDC 70934-518-20
Bottles of 30 tablets NDC 70934-518-30
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.
Inform parents and caregivers not to administer dicyclomine hydrochloride in infants less than 6 months of age [see Use in Specific Populations (8.4)] .
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)].
West-Ward Pharmaceuticals Corp.
Eatontown, NJ 07724
Revised May 2018
| DICYCLOMINE |
dicyclomine hydrochloride tablet
|Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)|
|Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)|
|Denton Pharma, Inc. DBA Northwind Pharmaceuticals||080355546||repack (70934-518)|
Revised: 01/2020 Denton Pharma, Inc. DBA Northwind Pharmaceuticals
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.