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 — 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 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 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 — 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 — 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
WELCHOL colesevelam hydrochloride tablet, film coated | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
|
WELCHOL colesevelam hydrochloride for suspension | |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
|
WELCHOL colesevelam hydrochloride for suspension | |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
|
WELCHOL colesevelam hydrochloride bar, chewable | ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
|
WELCHOL colesevelam hydrochloride bar, chewable | ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
|
WELCHOL colesevelam hydrochloride bar, chewable | ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
|
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.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.