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 Image

Dicyclomine Hydrochloride

Label 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