Helleborus Niger Root is a prescription medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Taken
- Oral
- Label
- Boiron, revised July 11, 2023 · full label on DailyMed
- Generic
- No · details
What it is used for
Nausea, vomiting, diarrhea*
Active ingredient
Helleborus niger 200CK (**contains 0.443 mg of the active ingredient per pellet)
Stop use and ask a doctor if
symptoms persist for more than 3 days or worsen
Pregnancy or breastfeeding
If pregnant or breast-feeding ask a health professional before use
Is there a generic Helleborus Niger Root?
No. The FDA has not approved a generic version yet.
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Helleborus niger root in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 85b5c79a-5177-e5c0-e053-2991aa0a6ca3.