Phytolacca decandra

PHYTOLACCA AMERICANA ROOT ORAL HUMAN OTC DRUG

Phytolacca decandra is an FDA drug label for the active ingredient PHYTOLACCA AMERICANA ROOT manufactured by Boiron 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 20231114.

Generic name
PHYTOLACCA AMERICANA ROOT
Manufacturer
Boiron
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
0220-4204
Application
N/A
Label effective
20231114

About this product

Phytolacca decandra is an FDA-registered drug product whose active ingredient is PHYTOLACCA AMERICANA ROOT. It is labelled by Boiron taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0220-4204, label effective 20231114. It is one of 10 FDA drug label records sharing the active ingredient PHYTOLACCA AMERICANA ROOT. 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 PHYTOLACCA AMERICANA ROOT are most often described in connection with: sore throat, pain radiating. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Phytolacca decandra 12C (**contains 0.443 mg of the active ingredient per pellet)

Indications & Usage

Sore Throat Pain Radiating To The Ears*

Dosage & Administration

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

More products with the same ingredient

PHYTOLACCA AMERICANA ROOT

PHYTOLACCA DECANDRA

Boiron View label

How products containing PHYTOLACCA AMERICANA ROOT compare

FDA lists 10 drug label records with PHYTOLACCA AMERICANA ROOT as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Boiron 10
— — — —
— — — —
— — — —
— — — —

Recall and safety notices

2 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-0803-2018 Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA Boiron Inc. Class III Terminated 20180523
D-0870-2021 La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Only, Liter LCL-2-0191-Bend: 12% Lycopodium Clavatum 10X, 12% Carbo Vegetabilis 16X, 12% Natrum Muriaticum 9X, 12% Calcarea Carbonica 12X, 10% Hypothalamus 30X, 6% Pituitarum Posterium 12X, 6% Pituitarum Posterium 30C, 3% Natrum Phosphoricum 12X, 3% Graphites 30X, 3# Agnus Castus 6X, 3% Thiosinaminum 8X, 3% Phytolacca Decandra 12X, 3% Magnesia Phosphorica 10X, 3% Ornithogalum Umbellatum 6X, 3% Chelidonium Majus 6X, 3% Quercus Robur 14X, 3% Nux Vomica 30X, Manufactured by Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. Washington Homeopathic Products, Inc. Class II Terminated 20211006

Frequently asked questions

What is Phytolacca decandra used for?
Sore Throat Pain Radiating To The Ears*

Who makes Phytolacca decandra?
Boiron is the labeler of record for Phytolacca decandra. 10 FDA label records share the active ingredient PHYTOLACCA AMERICANA ROOT, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Phytolacca decandra 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 Phytolacca decandra 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.

Are there other products containing PHYTOLACCA AMERICANA ROOT?
Yes. 10 FDA drug label records list PHYTOLACCA AMERICANA ROOT as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Phytolacca decandra been recalled?
2 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.