Drugplain

fiber laxative .52 g/1

Psyllium Husk · CAPSULE · Raritan Pharmaceuticals Inc

7 Recalls on Record
Plain English

Psyllium husk is a fiber-based laxative taken by mouth as a capsule to help relieve constipation and promote regular bowel movements. This medication works by adding bulk to stool and is available over the counter without a prescription.

Key Facts

Brand Name
fiber laxative
Generic Name
Psyllium Husk
NDC Code (Product)
68163-119
Manufacturer
Raritan Pharmaceuticals Inc
Strength
.52 g/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
04/16/2019

Recall History

7 Recalls on Record
Class II09/04/2012

Raritan Pharmaceuticals, Inc.

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

TerminatedVoluntary: Firm initiated
Class II09/04/2012

Raritan Pharmaceuticals, Inc.

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

TerminatedVoluntary: Firm initiated
Class II09/04/2012

Raritan Pharmaceuticals, Inc.

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

TerminatedVoluntary: Firm initiated
Class II09/04/2012

Raritan Pharmaceuticals, Inc.

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

TerminatedVoluntary: Firm initiated
Class II09/04/2012

Raritan Pharmaceuticals, Inc.

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

TerminatedVoluntary: Firm initiated
Class II09/04/2012

Raritan Pharmaceuticals, Inc.

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

TerminatedVoluntary: Firm initiated
Class III04/01/2014

Konsyl Pharmaceuticals Inc

Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

constipation299 reports
pain299 reports
off label use289 reports
headache238 reports
hypertension224 reports
exposure during pregnancy219 reports
pyrexia199 reports
intentional product misuse194 reports
overdose190 reports
fatigue186 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE(S) relieves occasional constipation this product generally produces bowel movement in 12 to 72 hours

Dosage & Administration

DIRECTIONS take this product (child or adult dose) with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. See choking warning. dosage will vary according to diet, exercise, previous laxative use or severity of constipation continued use for 1 to 3 days is normally required to provide full benefit adults and children 12 years and over 2 caplets, 1 to 4 times a day children under 12 years ask a doctor

Warnings

WARNINGS Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Frequently Asked Questions

What is fiber laxative used for?

Psyllium husk is a fiber-based laxative taken by mouth as a capsule to help relieve constipation and promote regular bowel movements. This medication works by adding bulk to stool and is available over the counter without a prescription.

Is fiber laxative a controlled substance?

fiber laxative is not classified as a controlled substance by the DEA.

What is the generic name for fiber laxative?

The generic name for fiber laxative is Psyllium Husk. There are 11 other brand versions of Psyllium Husk.

What is the NDC code for fiber laxative .52 g/1?

The NDC (National Drug Code) for fiber laxative .52 g/1 is 68163-119, listed by Raritan Pharmaceuticals Inc.