Taurine
Taurine is an FDA drug label for the active ingredient TAURINE manufactured by BioActive Nutritional 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 20171128.
- Generic name
- TAURINE
- Manufacturer
- BioActive Nutritional
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 43857-0229
- Application
- N/A
- Label effective
- 20171128
About this product
Taurine is an FDA-registered drug product whose active ingredient is TAURINE. It is labelled by BioActive Nutritional taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 43857-0229, label effective 20171128. 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 TAURINE are most often described in connection with: temporary relief, liver congestion, nervous anxiety, inability sleep. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
INDICATIONS: For temporary relief of liver congestion, nervous anxiety, irritability, and inability to sleep.
Dosage & Administration
DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Warnings
WARNINGS: If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
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-0066-2026 | Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | GenoGenix LLC | Class II | Ongoing | 20251015 |
| D-0251-2020 | S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compounding Rx | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | Class II | Terminated | 20191113 |
| D-0208-2020 | S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | Class II | Terminated | 20191113 |
| D-1709-2019 | TAURINE 50 MG/ML (MDV) INJECTABLE, 30 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0958-30 | RXQ Compounding LLC | Class II | Terminated | 20190814 |
| D-0473-2019 | Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Promise Pharmacy, LLC | Class II | Terminated | 20190220 |
Frequently asked questions
What is Taurine used for?
INDICATIONS: For temporary relief of liver congestion, nervous anxiety, irritability, and inability to sleep.
Who makes Taurine?
BioActive Nutritional is the labeler of record for Taurine.
What form does Taurine 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 Taurine 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 Taurine 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.