Dicyclomine Hydrochloride (Page 4 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

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

Product: 50090-0128

NDC: 50090-0128-0 30 CAPSULE in a BOTTLE, PLASTIC

NDC: 50090-0128-2 60 CAPSULE in a BOTTLE, PLASTIC

NDC: 50090-0128-8 90 CAPSULE in a BOTTLE, PLASTIC

Product: 50090-0130

NDC: 50090-0130-2 20 TABLET in a BOTTLE, PLASTIC

NDC: 50090-0130-8 90 TABLET in a BOTTLE, PLASTIC

NDC: 50090-0130-0 30 TABLET in a BOTTLE, 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 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)].

Manufactured For:
Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054

Rev. B 11/2020

Dicyclomine Hydrochloride

Label ImageLabel Image

Dicyclomine Hydrochloride

Label ImageLabel Image
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0128(NDC:0591-0794)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color BLUE (clear dark blue) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code WATSON;794;10;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0128-2 60 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:50090-0128-8 90 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:50090-0128-0 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085082 06/19/1986
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0130(NDC:0591-0795)
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
SILICON DIOXIDE
STARCH, CORN
FD&C BLUE NO. 1
HYPROMELLOSE 2910 (15 MPA.S)
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
LACTOSE MONOHYDRATE
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code WATSON;795
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0130-2 20 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:50090-0130-8 90 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:50090-0130-0 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085223 07/30/1986 08/01/2021
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-0130), RELABEL (50090-0128), REPACK (50090-0128), REPACK (50090-0130)

Revised: 08/2021 A-S Medication Solutions

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