FDA.reportPublic FDA data

Restless Leg

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:59

Label at a glance#

ProductRestless Leg
Active ingredientAVICULARIA AVICULARIA, CAUSTICUM, CINCHONA OFFICINALIS BARK, CONIUM MACULATUM FLOWERING TOP, COPPER, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, POTASSIUM CARBONATE, MAGNESIUM CARBONATE, MERCURY, AMANITA MUSCARIA FRUITING BODY, STRYCHNOS NUX-VOMICA SEED, LEAD, TOXICODENDRON PUBESCENS LEAF, CLAVICEPS PURPUREA SCLEROTIUM, STRYCHNINE, LYCOSA TARANTULA, VALERIAN, VERBASCUM THAPSUS, ZINC, MATRICARIA CHAMOMILLA, PASSIFLORA INCARNATA FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons being with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Passiflora incarnata 6x, Valeriana officinalis 6x, Agaricus muscarius 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Cuprum metallicum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Hypericum perforatum 15x, Kali carbonicum 15x, Magnesia carbonica 15x, Mercurius vivus 15x, Nux vomica 15x, Plumbum metallicum 15x, Rhus toxicodendron 15x, Secale cornutum 15x, Strychninum 15x, Tarentula hispana 15x, Valeriana officinalis 15x, Verbascum thapsus 15x, Zincum metallicum 15x, Mygale 16x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2555-1Restless Leg28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2555RESTLESS LEG (MYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORA) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250213_9b3f076e-7edd-ea51-e053-2a95a90abd9b.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-255555714-2555-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVICULARIA AVICULARIA8ZTK6T93B6ACTIB
CAUSTICUMDD5FO1WKFUACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
COPPER789U1901C5ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
MERCURYFXS1BY2PGLACTIB
AMANITA MUSCARIA FRUITING BODYDIF093I037ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
LEAD2P299V784PACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
STRYCHNINEH9Y79VD43JACTIB
LYCOSA TARANTULA86M454L2TTACTIB
VALERIANJWF5YAW3QWACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
ZINCJ41CSQ7QDSACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
SUCROSEC151H8M554IACT

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
Restless LegMYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORANewton Laboratories, Inc.9b3f076e-7edd-ea51-e053-2a95a90abd9b2025-02-10WarningsExact identifier
ndc (package): 55714-2555-1
ndc (product): 55714-2555
ndc11 (package): 55714255501
spl id: 2dd1e767-854d-eacb-e063-6294a90abe9e
spl set id: 9b3f076e-7edd-ea51-e053-2a95a90abd9b

Reported adverse events (FAERS/openFDA)#

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