Senna

SENNOSIDES 8.6 MG TABLETS ORAL HUMAN OTC DRUG

Senna is an FDA drug label for the active ingredient SENNOSIDES 8.6 MG TABLETS manufactured by Aarkish Pharmaceuticals NJ Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260701.

Generic name
SENNOSIDES 8.6 MG TABLETS
Manufacturer
Aarkish Pharmaceuticals NJ Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
81005-101
Application
M007
Label effective
20260701

About this product

Senna is an FDA-registered drug product whose active ingredient is SENNOSIDES 8.6 MG TABLETS. It is labelled by Aarkish Pharmaceuticals NJ Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 81005-101, application M007, label effective 20260701. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing SENNOSIDES 8.6 MG TABLETS are most often described in connection with: relieve occasional, constipation irregularity, product generally, produces bowel, movement hours. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

ACTIVE INGREDIENT(S) Sennosides 8.6 mg

Indications & Usage

USE(S) relieve occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours

Dosage & Administration

DIRECTIONS take preferably at bedtime or as directed by a doctor do not exceed maximum dosage age starting dose maximum dosage adults and children 12 years of age or older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Warnings

WARNINGS ASK A DOCTOR BEFORE USE IF stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks STOP USE AND ASK DOCTOR IF you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition. PREGNANCY/BREASTFEEDING 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.

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0377-2022 SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24. Lohxa, LLC Class I Terminated 20220126
D-1437-2019 Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08 Geritrex, LLC Class II Terminated 20190619
D-1436-2019 Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08 Geritrex, LLC Class II Terminated 20190619
D-0850-2018 Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088 RIJ Pharmaceutical LLC Class II Terminated 20180620
D-0844-2018 RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080 RIJ Pharmaceutical LLC Class II Terminated 20180620

Frequently asked questions

What is Senna used for?
USE(S) relieve occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours

Who makes Senna?
Aarkish Pharmaceuticals NJ Inc. is the labeler of record for Senna.

What form does Senna come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Senna prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Senna been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.