FDA.reportPublic FDA data

Muscle Ease

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:59

Label at a glance#

ProductMuscle Ease
Active ingredientCOMFREY ROOT, ACONITUM NAPELLUS, ANTIMONY POTASSIUM TARTRATE, SILVER NITRITE, ARNICA MONTANA, BRYONIA ALBA ROOT, CHELIDONIUM MAJUS, BLACK COHOSH, EUPATORIUM PERFOLIATUM FLOWERING TOP, MATRICARIA CHAMOMILLA, STRYCHNOS NUX-VOMICA SEED, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, LACTIC ACID, L-, DATURA STRAMONIUM, STRYCHNINE, PHYTOLACCA AMERICANA ROOT, HYPERICUM PERFORATUM
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as bruising, pain, soreness, stiffness, spasms and weakness..

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 begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Phytolacca decandra 6x, Ruta graveolens 6x, Symphytum officinale 6x, Aconitum napellus 15x, Antimonium tartaricum 15x, Argentum nitricum 15x, Arnica montana 15x, Bryonia 15x, Chamomilla 15x, Chelidonium majus 15x, Cimicifuga racemosa 15x, Eupatorium perfoliatum 15x, Hypericum perforatum 15x, Nux vomica 15x, Rhus toxicodendron 15x, Ruta graveolens 15x, Sarcolacticum acidum 15x, Stramonium 15x, Strychninum 15

OTC - PURPOSE SECTION

Formulated for associated symptoms such as bruising, pain, soreness, stiffness, spasms and weakness.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organice 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2488-1Muscle Ease28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2488MUSCLE EASE (CHAMOMILLA, PHYTOLACCA DECANDRA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARGENTUM NITRICUM, ARNICA MONTANA, BRYONIA, CHAMOMILLA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, EUPATORIUM PERFOLIATUM, HYPERICUM PERFORATUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, STRAMONIUM, STRYCHNINUM.) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250213_9c5b8025-9c59-997e-e053-2a95a90ac6ce.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-248855714-2488-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
COMFREY ROOTM9VVZ08EKQACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
SILVER NITRITET3MZ57OGIFACTIB
ARNICA MONTANAO80TY208ZWACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
BLACK COHOSHK73E24S6X9ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
LACTIC ACID, L-F9S9FFU82NACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
STRYCHNINEH9Y79VD43JACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
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
Muscle EaseCHAMOMILLA, PHYTOLACCA DECANDRA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARGENTUM NITRICUM, ARNICA MONTANA, BRYONIA, CHAMOMILLA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, EUPATORIUM PERFOLIATUM, HYPERICUM PERFORATUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, STRAMONIUM, STRYCHNINUM.Newton Laboratories, Inc.9c5b8025-9c59-997e-e053-2a95a90ac6ce2025-02-11WarningsExact identifier
ndc (package): 55714-2488-1
ndc (product): 55714-2488
ndc11 (package): 55714248801
spl id: 2de184b0-fe97-a525-e063-6394a90a68a7
spl set id: 9c5b8025-9c59-997e-e053-2a95a90ac6ce

Reported adverse events (FAERS/openFDA)#

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