Drugplain

Laxative 25 mg/1

Sennosides · TABLET, FILM COATED · Family Dollar Services Inc

10 Recalls on Record
Plain English

Laxative is a tablet, film coated containing sennosides at 25 mg/1, taken oral. Manufactured by Family Dollar Services Inc.

Key Facts

Brand Name
Laxative
Generic Name
Sennosides
NDC Code (Product)
55319-773
Manufacturer
Family Dollar Services Inc
Strength
25 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
02/09/2024

Recall History

10 Recalls on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II12/21/2023

Pharma Nobis LLC

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

OngoingVoluntary: Firm initiated
Class II07/17/2017

Vi-Jon, Inc.

Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.

TerminatedVoluntary: Firm initiated
Class II12/21/2023

Pharma Nobis LLC

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

OngoingVoluntary: 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 II08/16/2017

Pharmatech LLC

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

TerminatedVoluntary: Firm initiated
Class III10/01/2019

Sato Pharmaceutical Inc.

Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.

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 I07/15/2022

Vi-Jon, LLC

Microbial contamination of non-sterile products.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea5,495 reports
drug ineffective5,388 reports
off label use4,948 reports
fatigue4,875 reports
constipation4,813 reports
pain4,506 reports
diarrhoea4,363 reports
dyspnoea3,900 reports
vomiting3,800 reports
headache3,639 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Directions -detach one suppository from the strip -remove wrapper before inserting into the rectum adults and children 12 years of age and older 1 suppository once daily children 6 to under 12 years 1/2 suppository once daily children under 6 years do not use

Dosage & Administration

Directions -detach one suppository from the strip -remove wrapper before inserting into the rectum adults and children 12 years of age and older 1 suppository once daily children 6 to under 12 years 1/2 suppository once daily children under 6 years do not use

Warnings

Warnings For rectal use only.

Frequently Asked Questions

What is Laxative used for?

Laxative contains Sennosides. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Laxative a controlled substance?

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

What is the generic name for Laxative?

The generic name for Laxative is Sennosides. There are 12 other brand versions of Sennosides.

What is the NDC code for Laxative 25 mg/1?

The NDC (National Drug Code) for Laxative 25 mg/1 is 55319-773, listed by Family Dollar Services Inc.