Drugplain

Senna 8.8 mg/5mL

Senna · SOLUTION · Rugby Laboratories

10 Recalls on Record
Plain English

Senna is an over-the-counter oral solution used to treat constipation by stimulating bowel movements. Each 5mL dose contains 8.8 mg of senna, a natural laxative derived from plant leaves.

Key Facts

Brand Name
Senna
Generic Name
Senna
NDC Code (Product)
0536-1483
Manufacturer
Rugby Laboratories
Strength
8.8 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
04/17/2026

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 II05/06/2019

Geritrex, LLC

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

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 II08/02/2017

The Harvard Drug Group

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

TerminatedVoluntary: Firm initiated
Class II05/06/2019

Geritrex, LLC

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

TerminatedVoluntary: Firm initiated
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 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 II05/07/2018

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 I12/21/2021

Lohxa, LLC

Microbial Contamination of Non-Sterile Product

TerminatedVoluntary: Firm initiated
Class I01/17/2018

Magno Humphries Laboratories, Inc

Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue2,490 reports
nausea2,227 reports
constipation2,131 reports
dyspnoea1,910 reports
death1,836 reports
off label use1,762 reports
diarrhoea1,719 reports
pain1,707 reports
pyrexia1,707 reports
headache1,614 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions take preferably at bedtime or as directed by a doctor adults and children 12 years of age or older - starting dosage: 2 tablets once a day, maximum dosage: 4 tablets twice a day children 6 to under 12 years - starting dosage: 1 tablet once a day, maximum dosage: 2 tablets twice a day children 2 to under 6 years - starting dosage: 1/2 tablet once a day, maximum dosage: 1 tablet twice a day children under 2 years - starting dosage: ask a doctor, maximum dosage: ask a doctor

Warnings

Warnings Do not use if you are now taking mineral oil, unless directed by a doctor laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if you have 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 fail to have a bowel movement after use of a laxative. These may indicate a serious condition. 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 Senna used for?

Senna is an over-the-counter oral solution used to treat constipation by stimulating bowel movements. Each 5mL dose contains 8.8 mg of senna, a natural laxative derived from plant leaves.

Is Senna a controlled substance?

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

What is the generic name for Senna?

The generic name for Senna is Senna. There are 10 other brand versions of Senna.

What is the NDC code for Senna 8.8 mg/5mL?

The NDC (National Drug Code) for Senna 8.8 mg/5mL is 0536-1483, listed by Rugby Laboratories.