Homeopathic Restless Leg Formula

Manufacturer
Indiana Botanic Gardens | ASI Marketing Group
Effective date
2016-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:58

Label at a glance#

ProductHomeopathic Restless Leg Formula
Active ingredientARSENIC TRIOXIDE, CAUSTICUM, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, TOXICODENDRON PUBESCENS LEAF
Label structure12 sections

Label contents#

Full prescribing information#

Ingredients:

OTC - ACTIVE INGREDIENT SECTION

White Oxide of Arsenic...... 4C HPUS

Potassium Hydrate............ 4C HPUS

Carbonate of Potassium...... 4C HPUS

Club Moss ......................... 4C HPUS

Poison Oak........................ 4C HPUS

SPL UNCLASSIFIED SECTION

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Dextrose, Magnesium Stearate, Silica.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: INDIANA BOTANIC GARDENS, INC.

3401 W. 37TH AVE. HOBART, IN 46342

Suggested Use:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years, take 2 tablets at onset of symptoms, repeat every 2 hours up to 4 times daily, or as directed by a health professional.

Warning:

WARNINGS SECTION

If you are taking any medications or are pregnant or breast feeding do not use prior to consulting a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

For your protection, this container has an outer safety seal. (Do not accept if missing or broken.)

Best if used by date on bottle. Store in a dry cool place.

OTC - PURPOSE SECTION

Leg discomfort.

INDICATIONS & USAGE SECTION

Leg discomfort.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Homeopathic Restless Leg Formula

Leg discomfort.

90 TABLETS

image of label
image of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10578-119-902021-01-15C16284748780-19d75b9d0-e2ba-f424-e053-dadaa90a57ceHomeopathic Restless Leg Formula
10578-119-902020-01-31C16284748780-19d75b9d0-e2ba-f424-e053-dadaa90a57ceHomeopathic Restless Leg Formula

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10578-11910578-119-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
87dc2c85-af7c-4244-b785-c5002c62c401bdf105a3-ca72-4e9a-8673-f286aae2121c2021-01-15WarningsExact identifier
spl set id: bdf105a3-ca72-4e9a-8673-f286aae2121c

Reported adverse events (FAERS/openFDA)#

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