Colesevelam HCL (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-4371

NDC: 50090-4371-0 90 TABLET, FILM COATED in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Hypertriglyceridemia and Pancreatitis

Inform patients that colesevelam hydrochloride may increase their serum triglycerides which can lead to hypertriglyceridemia and pancreatitis. Instruct patients to discontinue colesevelam hydrochloride and seek prompt medical attention if the symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting) [see Warnings and Precautions (5.1)].

Gastrointestinal

Inform patients that colesevelam hydrochloride may cause bowel obstruction. Instruct patients to promptly discontinue colesevelam hydrochloride and seek medical attention if severe abdominal pain or severe constipation occurs [see Warnings and Precautions (5.2)].

Drug and Vitamin Interactions

Advise patients that colesevelam hydrochloride has drug interactions and colesevelam hydrochloride may decrease the absorption of fat-soluble vitamins A, D, E, and K. Instruct patients to take oral vitamins at least 4 hours prior to colesevelam hydrochloride. Instruct patients to inform their physician about all the drugs and vitamins that they are prescribed or take over the counter [see Warnings and Precautions (5.3) and Drug Interactions (7)].

Hypertriglyceridemia and Cardiovascular Disease

Inform patients that colesevelam hydrochloride may increase serum triglycerides and that the long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain [see Warnings and Precautions (5.1)].

Administration [see Dosage and Administration (2.2, 2.4 )]

Tablets
Advise patients to take colesevelam hydrochloride tablets with a meal and liquid. Inform patients that colesevelam hydrochloride tablets can be taken as 6 tablets once daily or 3 tablets twice daily.

Females of Reproductive Potential

Advise females of reproductive potential that colesevelam hydrochloride may reduce the effectiveness of oral contraceptives, and to take oral contraceptives at least 4 hours before taking colesevelam hydrochloride [see Drug Interactions (7.1) and Use in Specific Populations (8.3)].

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: November, 2021

PT 2632-04

Storage

Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Brief exposure to 40°C (104°F) does not adversely affect the product. Protect from moisture.

Colesevelam HCL

Label Image

COLESEVELAM HCL colesevelam hcl tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4371(NDC:67877-506) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COLESEVELAM HYDROCHLORIDE (COLESEVELAM) COLESEVELAM HYDROCHLORIDE 625 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE MAGNESIUM STEARATE SODIUM STEARYL FUMARATE HYPROMELLOSE 2910 (15 MPA.S) PROPYLENE GLYCOL SHELLAC FERROSOFERRIC OXIDE BUTYL ALCOHOL AMMONIA

Product Characteristics Color YELLOW (Off-white to light yellow) Score no score Shape OVAL Size 19mm Flavor Imprint Code C625 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50090-4371-0 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209038 10/06/2018

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-4371), REPACK (50090-4371)

Revised: 02/2023 A-S Medication Solutions