Drugplain

SENNOSIDES 15 mg/1

SENNOSIDES · TABLET, SUGAR COATED · TIME CAP LABORATORIES, INC

10 Recalls on Record
Plain English

SENNOSIDES is a tablet, sugar coated containing sennosides at 15 mg/1, taken oral. Manufactured by TIME CAP LABORATORIES, INC.

Key Facts

Brand Name
SENNOSIDES
Generic Name
SENNOSIDES
NDC Code (Product)
49483-079
Manufacturer
TIME CAP LABORATORIES, INC
Strength
15 mg/1
Dosage Form
TABLET, SUGAR COATED
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
08/30/2018

Recall History

10 Recalls on Record
Class II05/07/2018

RIJ Pharmaceutical LLC

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

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 II08/08/2016

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

TerminatedVoluntary: Firm initiated
Class II05/06/2019

Geritrex, LLC

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling:Label Mixup; SENNOSIDES Tablet, 8.6 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD37063_7, EXP: 5/13/2014.

TerminatedVoluntary: Firm initiated
Class II05/07/2018

RIJ Pharmaceutical LLC

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

TerminatedVoluntary: Firm initiated
Class II08/08/2016

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

TerminatedVoluntary: Firm initiated
Class II05/06/2019

Geritrex, LLC

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

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 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

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours

Dosage & Administration

Directions take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and older: take 2-4 tablets daily children 6 to under 12 years of age: take 1-2 tablets daily children 2 to under 6 years of age: take up to 1 tablet daily children under 2 years: ask a doctor

Warnings

Warnings

Frequently Asked Questions

What is SENNOSIDES used for?

SENNOSIDES contains SENNOSIDES. It is a tablet, sugar coated taken oral. Consult your doctor for specific uses.

Is SENNOSIDES a controlled substance?

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

What is the generic name for SENNOSIDES?

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

What is the NDC code for SENNOSIDES 15 mg/1?

The NDC (National Drug Code) for SENNOSIDES 15 mg/1 is 49483-079, listed by TIME CAP LABORATORIES, INC.