Senna
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
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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| 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.