Drugplain

STIMULANT LAXATIVE 5 mg/1

BISACODYL · TABLET, DELAYED RELEASE · TIME CAP LABORATORIES, INC.

3 Recalls on Record
Plain English

STIMULANT LAXATIVE is a tablet, delayed release containing bisacodyl at 5 mg/1, taken oral. Manufactured by TIME CAP LABORATORIES, INC..

Key Facts

Brand Name
STIMULANT LAXATIVE
Generic Name
BISACODYL
NDC Code (Product)
49483-003
Manufacturer
TIME CAP LABORATORIES, INC.
Strength
5 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
part334
Drug Class
Stimulant Laxative [EPC]
Marketing Start
04/01/2014

Recall History

3 Recalls on Record
Class III06/28/2012

Health Plus Incorporated

Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.

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 II06/20/2012

Medtech Products, Inc.

Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

constipation2,175 reports
drug ineffective1,950 reports
nausea1,941 reports
pain1,790 reports
off label use1,733 reports
fatigue1,476 reports
dyspnoea1,419 reports
vomiting1,356 reports
pyrexia1,331 reports
headache1,278 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours

Dosage & Administration

Directions take with a glass of water do not take more than directed adults and children 12 years and older: take 1 to 3 tablets in a single daily dose children 12 and under: ask a doctor

Warnings

Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have • stomach pain, nausea, vomiting • noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product • do not chew or crush tablet(s) • do not use within 1 hour after taking an antacid or milk • it may cause stomach discomfort, faintness and cramps Stop use and ask a doctor if • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. • you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is STIMULANT LAXATIVE used for?

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

Is STIMULANT LAXATIVE a controlled substance?

STIMULANT LAXATIVE is not classified as a controlled substance by the DEA.

What is the generic name for STIMULANT LAXATIVE?

The generic name for STIMULANT LAXATIVE is BISACODYL. There are 11 other brand versions of BISACODYL.

What is the NDC code for STIMULANT LAXATIVE 5 mg/1?

The NDC (National Drug Code) for STIMULANT LAXATIVE 5 mg/1 is 49483-003, listed by TIME CAP LABORATORIES, INC..

Product NDC

49483-003

Package NDC

49483-003-00

Other Bisacodyl Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)