FDA.reportPublic FDA data

Polygonum

Manufacturer
Marco Pharma International LLC. | Nestmann Pharma GmbH
Effective date
2021-12-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:23:41

Label at a glance#

ProductPolygonum
Active ingredientPOTASSIUM IODIDE, ICHTHAMMOL, COMFREY ROOT, POLYGONUM AVICULARE TOP, ACORUS CALAMUS WHOLE, TOXICODENDRON PUBESCENS LEAF, PSEUDOGNAPHALIUM OBTUSIFOLIUM, RHODODENDRON AUREUM LEAF, CITRULLUS COLOCYNTHIS FRUIT PULP, COLCHICUM AUTUMNALE BULB
Label structure2 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Buckwheat 1x

Sweetflag 1x

Poison oak 4xHPUS

Common everlasting 2xHPUS

Golden flower rhododendron 3xHPUS

Colocynth 3xHPUS

Meadow saffron 3xHPUS

Potassium iodide 4xHPUS

ichthammol 3xHPUS

Comfrey 1XHPUS

The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

Purpose

OTC - PURPOSE SECTION

Relief of pain in joints and muscles.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Suggested use

INDICATIONS & USAGE SECTION

Adults: take 30 drops in a glass of tepid water three to five times daily. For acute rheumatic symptoms, take 10 - 15 drops in waterevery hour. As maintenance take 30 drops two times daily. Children receive 1/2 or less of the adult amount.

Warnings

WARNINGS SECTION

If pregnant or breast-feeding, consult a health professional before use.

DOSAGE & ADMINISTRATION SECTION

(Read Suggested Use Section)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ethyl Alcohol (50.2% by vol.) and Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Polygonum_N1S072_N1L073Polygonum_N1S072_N1L073

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60986-1031-32020-12-04C16284748780-19d75b9d0-6964-f424-e053-dadaa90a57ceDrug Facts
60986-1031-42020-12-04C16284748780-19d75b9d0-6964-f424-e053-dadaa90a57ceDrug Facts
60986-1031-32020-01-31C16284748780-19d75b9d0-6964-f424-e053-dadaa90a57ceDrug Facts
60986-1031-42020-01-31C16284748780-19d75b9d0-6964-f424-e053-dadaa90a57ceDrug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60986-103160986-1031-3, 60986-1031-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM IODIDE1C4QK22F9JACTIM
ICHTHAMMOLNQ14646378ACTIB
COMFREY ROOTM9VVZ08EKQACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
POLYGONUM AVICULARE TOPZCD6009IUFACTIB
ACORUS CALAMUS WHOLEQ46A6NDR5CACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
PSEUDOGNAPHALIUM OBTUSIFOLIUM36XQ854NWWACTIB
RHODODENDRON AUREUM LEAFIV92NQJ73UACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f0d815ca-9944-7716-e053-2a95a90ae574cfaceaf2-07a3-419a-a958-fe1b89867f842022-12-27WarningsExact identifier
spl set id: cfaceaf2-07a3-419a-a958-fe1b89867f84

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.