Dicyclomine (Page 3 of 3)

NONCLINICAL TOXICOLOGY

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on breeding, conception, or parturition.

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).

HOW SUPPLIED

Dicyclomine Hydrochloride Capsules, USP, 10 mg are supplied as dark blue capsules printed “West-ward 3126″ and are available in:
Bottles of 100 capsules.
Bottles of 1000 capsules.

Dicyclomine Hydrochloride Tablets, USP 20 mg are supplied as Blue, Round Tablets; Embossed “WW27″ and are available in:
Bottles of 100 tablets.
Bottles of 1000 tablets.
Unit Dose Boxes of 100 tablets.

INFORMATION FOR PATIENTS

Inform parents and caregivers not to administer dicyclomine hydrochloride in infants less than 6 months of age [see Use in Specific Populations (8.4)] .

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)] .

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 patients 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)].

Manufactured By:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724 USA

Revised September 2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Dicyclomine
GENERIC: Dicyclomine Hydrochloride
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 24236-231-20
STRENGTH:20 mg
COLOR: blue
SHAPE: ROUND
SCORE: No score
SIZE: 7 mm
IMPRINT: 100
QTY: 100
MM2
(click image for full-size original)
MM3
(click image for full-size original)
DICYCLOMINE dicyclomine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24236-231(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 Score no score
Shape ROUND (TABLET) Size 7mm
Flavor Imprint Code WW;27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24236-231-20 100 TABLET (TABLET) in 1 CANISTER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040161 03/15/2013
Labeler — REMEDYREPACK INC. (829572556)

Revised: 03/2013 REMEDYREPACK INC.

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