Drugplain

Stool Softener Laxative 50 mg/1

docusate sodium and sennosides · TABLET · Strategic Sourcing Services LLC

6 Recalls on Record
Plain English

Stool Softener Laxative is a tablet containing docusate sodium and sennosides at 50 mg/1, taken oral. Manufactured by Strategic Sourcing Services LLC.

Key Facts

Brand Name
Stool Softener Laxative
Generic Name
docusate sodium and sennosides
NDC Code (Product)
62011-0417
Manufacturer
Strategic Sourcing Services LLC
Strength
50 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
10/01/2020

Recall History

6 Recalls on Record
Class II08/16/2017

Pharmatech LLC

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

TerminatedVoluntary: Firm initiated
Class I07/15/2016

The Harvard Drug Group

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

TerminatedVoluntary: Firm initiated
Class II08/02/2017

The Harvard Drug Group

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

TerminatedVoluntary: Firm initiated
Class II08/02/2017

The Harvard Drug Group

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

TerminatedVoluntary: Firm initiated
Class II10/15/2024

Akron Pharma, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II08/16/2017

Pharmatech LLC

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue1,664 reports
nausea1,663 reports
dyspnoea1,417 reports
diarrhoea1,274 reports
constipation1,261 reports
vomiting1,212 reports
pain1,211 reports
death1,166 reports
off label use1,133 reports
pneumonia1,026 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 12 to 72 hours

Dosage & Administration

Directions take with a glass of water adults and children 12 years and over take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

Warnings

Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using a laxative. These could be a sign of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away.

Frequently Asked Questions

What is Stool Softener Laxative used for?

Stool Softener Laxative contains docusate sodium and sennosides. It is a tablet taken oral. Consult your doctor for specific uses.

Is Stool Softener Laxative a controlled substance?

Stool Softener Laxative is not classified as a controlled substance by the DEA.

What is the generic name for Stool Softener Laxative?

The generic name for Stool Softener Laxative is docusate sodium and sennosides. There are 8 other brand versions of docusate sodium and sennosides.

What is the NDC code for Stool Softener Laxative 50 mg/1?

The NDC (National Drug Code) for Stool Softener Laxative 50 mg/1 is 62011-0417, listed by Strategic Sourcing Services LLC.