Welchol (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

WELCHOL 625 mg tablets are supplied as off-white, solid tablets imprinted with the word “Sankyo” and “C01” on one side and are available as follows:

  • Bottles of 180 – NDC 65597-701-18

WELCHOL 3.75 gram packets for oral suspension contain a white to pale yellow powder containing yellow granules and are available as follows:

  • Cartons of 30 packets – NDC 65597-902-30

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

17 PATIENT COUNSELING INFORMATION

Hypertriglyceridemia and Pancreatitis

Inform patients that WELCHOL may increase their serum triglycerides which can lead to hypertriglyceridemia and pancreatitis. Instruct patients to discontinue WELCHOL 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 WELCHOL may cause bowel obstruction. Instruct patients to promptly discontinue WELCHOL 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 WELCHOL has drug interactions, and WELCHOL 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 WELCHOL. 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 WELCHOL 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 WELCHOL tablets with a meal and liquid. Inform patients that WELCHOL tablets can be taken as 6 tablets once daily or 3 tablets twice daily.

For Oral Suspension

Instruct patients to empty the entire contents of one packet into a glass or cup and add 1 cup (8 ounces) of water, fruit juice, or diet soft drinks. Stir well and drink. Advise patients to take WELCHOL oral suspension with meals. Advise patient to not take WELCHOL oral suspension in its dry form.

Females of Reproductive Potential

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

Marketed by:
Daiichi Sankyo, Inc.
Basking Ridge, New Jersey 07920

USPI-WEL-1021-r105

PRINCIPAL DISPLAY PANEL

NDC 65597-701-18
TABLETS
Welchol
(colesevelam HCl)
180 TABLETS625 mg

PRINCIPAL DISPLAY PANEL NDC 65597-701-18 TABLETS Welchol (colesevelam HCI) 180 TABLETS 625 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3.75 g Packet Label

TEAR HERE
No cutting required

Sugar-Free

This packet is contained within the
CARTON NDC 65597-902-30

Welchol™
(colesevelam HCl)
For Oral Suspension

3.75 g

Citrus Flavor
Single-Dose Packet

Each packet contains 3.75 grams of
colesevelam hydrochloride.

Rx only

Keep Out of Reach of Children.Package Not Child Resistant.

PRINCIPAL DISPLAY PANEL -- 3.75 g Packet Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3.75 g Packet Carton

Keep Out of Reach of Children.
Package Not Child Resistant.

NDC 65597-902-30

30 packets

Welchol™
(colesevelam HCl)For Oral Suspension

3.75 g

Each packet contains 3.75 grams of colesevelam hydrochloride.

Rx only

Dosing and use: see package insert.

PRINCIPAL DISPLAY PANEL -- 3.75 g Packet Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3.75 g Bar Package Carton — 209-30

NDC 65587-209-30

Welchol®
(colesevelam HCl)
Chewable Bar

3.75 g

30 CHEWABLE BARS

RX ONLY

EACH BAR CONTAINS 3.75 g
OF COLESEVELAM HYDROCHLORIDE

CHILD-RESISTANT WRAPPERS

CONTAINS MEDICATION
KEEP OUT OF REACH OF CHILDREN

DOSING AND USE:
SEE PACKAGE INSERT

NOTE TO PHARMACISTS:DO NOT BREAK BOX. DISPENSE AS 1 BOX.

CHOCOLATE FLAVOR

PRINCIPAL DISPLAY PANEL -- 3.75 g Bar Package Carton -- 209-30
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3.75 g Bar Package Carton — 210-30

NDC 65587-210-30

Welchol®
(colesevelam HCl)
Chewable Bar

3.75 g

30 CHEWABLE BARS

RX ONLY

EACH BAR CONTAINS 3.75 g
OF COLESEVELAM HYDROCHLORIDE

CHILD-RESISTANT WRAPPERS

CONTAINS MEDICATION
KEEP OUT OF REACH OF CHILDREN

DOSING AND USE:
SEE PACKAGE INSERT

NOTE TO PHARMACISTS:DO NOT BREAK BOX. DISPENSE AS 1 BOX.

STRAWBERRY FLAVOR

PRINCIPAL DISPLAY PANEL -- 3.75 g Bar Package Carton -- 210-30
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3.75 g Bar Package Carton — 208-30

NDC 65587-208-30

Welchol®
(colesevelam HCl)
Chewable Bar

3.75 g

30 CHEWABLE BARS

RX ONLY

EACH BAR CONTAINS 3.75 g
OF COLESEVELAM HYDROCHLORIDE

CHILD-RESISTANT WRAPPERS

CONTAINS MEDICATION
KEEP OUT OF REACH OF CHILDREN

DOSING AND USE:
SEE PACKAGE INSERT

NOTE TO PHARMACISTS:DO NOT BREAK BOX. DISPENSE AS 1 BOX.

CARAMEL FLAVOR

PRINCIPAL DISPLAY PANEL -- 3.75 g Bar Package Carton -- 208-30
(click image for full-size original)
WELCHOL colesevelam hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-701
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code Sankyo;C01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-701-18 180 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021176 09/01/2000 09/30/2025
WELCHOL colesevelam hydrochloride for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-903
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESEVELAM HYDROCHLORIDE (COLESEVELAM) COLESEVELAM HYDROCHLORIDE 1.875 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
MAGNESIUM TRISILICATE
ASPARTAME
DIMETHICONE
GLYCERYL MONO AND DICAPRYLOCAPRATE
PROPYLENE GLYCOL ALGINATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-903-60 60 PACKET in 1 CARTON contains a PACKET
1 1 FOR SUSPENSION in 1 PACKET This package is contained within the CARTON (65597-903-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022362 01/01/2010 01/16/2019
WELCHOL colesevelam hydrochloride for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-902
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESEVELAM HYDROCHLORIDE (COLESEVELAM) COLESEVELAM HYDROCHLORIDE 3.75 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
MAGNESIUM TRISILICATE
ASPARTAME
DIMETHICONE
GLYCERYL MONO AND DICAPRYLOCAPRATE
PROPYLENE GLYCOL ALGINATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-902-30 30 PACKET in 1 CARTON contains a PACKET
1 1 FOR SUSPENSION in 1 PACKET This package is contained within the CARTON (65597-902-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022362 01/01/2010 02/28/2026
WELCHOL colesevelam hydrochloride bar, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-209
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESEVELAM HYDROCHLORIDE (COLESEVELAM) COLESEVELAM HYDROCHLORIDE 3.75 g
Inactive Ingredients
Ingredient Name Strength
MALTITOL
MALTODEXTRIN
PALM OIL
GLYCERIN
LECITHIN, SOYBEAN
VANILLA BEAN
ROSEMARY
SUCRALOSE
COCOA
Product Characteristics
Color BROWN Score no score
Shape RECTANGLE (oblong, rectangular bar) Size 96mm
Flavor CHOCOLATE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-209-30 30 PACKAGE in 1 CARTON contains a PACKAGE
1 1 BAR, CHEWABLE in 1 PACKAGE This package is contained within the CARTON (65597-209-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210895 04/04/2019 04/04/2019
WELCHOL colesevelam hydrochloride bar, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-210
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESEVELAM HYDROCHLORIDE (COLESEVELAM) COLESEVELAM HYDROCHLORIDE 3.75 g
Inactive Ingredients
Ingredient Name Strength
MALTITOL
MALTODEXTRIN
PALM OIL
GLYCERIN
LECITHIN, SOYBEAN
ROSEMARY
SUCRALOSE
ACACIA
FD&C RED NO. 40
ANHYDROUS CITRIC ACID
Product Characteristics
Color PINK Score no score
Shape RECTANGLE (oblong, rectangular bar) Size 96mm
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-210-30 30 PACKAGE in 1 CARTON contains a PACKAGE
1 1 BAR, CHEWABLE in 1 PACKAGE This package is contained within the CARTON (65597-210-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210895 04/04/2019 04/04/2019
WELCHOL colesevelam hydrochloride bar, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESEVELAM HYDROCHLORIDE (COLESEVELAM) COLESEVELAM HYDROCHLORIDE 3.75 g
Inactive Ingredients
Ingredient Name Strength
MALTITOL
MALTODEXTRIN
PALM OIL
GLYCERIN
LECITHIN, SOYBEAN
VANILLA BEAN
ROSEMARY
SUCRALOSE
ACACIA
CARAMEL
Product Characteristics
Color BROWN (Tan) Score no score
Shape RECTANGLE (oblong, rectangular bar) Size 96mm
Flavor CARAMEL Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-208-30 30 PACKAGE in 1 CARTON contains a PACKAGE
1 1 BAR, CHEWABLE in 1 PACKAGE This package is contained within the CARTON (65597-208-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210895 04/04/2019 04/04/2019
Labeler — Daiichi Sankyo Inc. (068605067)
Establishment
Name Address ID/FEI Operations
Powdersize, LLC 080120056 PARTICLE SIZE REDUCTION (65597-701), PARTICLE SIZE REDUCTION (65597-902)

Revised: 06/2022 Daiichi Sankyo Inc.

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