Drugplain

Bisacodyl 5 mg/1

Bisacodyl · TABLET, DELAYED RELEASE · Chain Drug Consortium

8 Recalls on Record
Plain English

Bisacodyl is a tablet, delayed release containing bisacodyl at 5 mg/1, taken oral. Manufactured by Chain Drug Consortium.

Key Facts

Brand Name
Bisacodyl
Generic Name
Bisacodyl
NDC Code (Product)
68016-688
Manufacturer
Chain Drug Consortium
Strength
5 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
505G(a)(3)
Drug Class
Stimulant Laxative [EPC]
Marketing Start
03/25/2002

Recall History

8 Recalls on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class III07/15/2013

Braintree Laboratories Inc.

Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; BISACODYL EC, Tablet, 5 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD37056_13, EXP: 5/10/2014.

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

constipation1,427 reports
nausea1,306 reports
drug ineffective1,294 reports
off label use1,100 reports
pain1,088 reports
vomiting949 reports
fall822 reports
dyspnoea808 reports
pneumonia781 reports
macular degeneration779 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use for relief of occasional constipation (irregularity) this product generally produces bowel movement in 15 minutes to 1 hour

Dosage & Administration

Directions adults and children 12 years of age and over 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes children 6 to under 12 years 1/2 suppository in a single daily dose children under 6 years Do not use

Warnings

Warnings For rectal use only

Frequently Asked Questions

What is Bisacodyl used for?

Bisacodyl contains Bisacodyl. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is Bisacodyl a controlled substance?

Bisacodyl is not classified as a controlled substance by the DEA.

What is the generic name for Bisacodyl?

The generic name for Bisacodyl is Bisacodyl. There are 11 other brand versions of Bisacodyl.

What is the NDC code for Bisacodyl 5 mg/1?

The NDC (National Drug Code) for Bisacodyl 5 mg/1 is 68016-688, listed by Chain Drug Consortium.