FDA.reportPublic FDA data

Muscle-Tendon

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:52

Label at a glance#

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

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as painful tendons, muscle pain or weakness, muscle spasms or difficulty in relaxing muscles.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Phytolacca 6x, Ruta 6x, Symphytum 6x Aconitum nap. 15x, Antimon. tart. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Chamomilla 15x, Chelidonium majus 15x, Cimicifuga 15x, Eupatorium perf. 15x, Hypericum 15x, Nux vom. 15x, Rhus toxicodendron 15x, Ruta 15x,Sarcolacticum ac. 15x, Stramonium 15x, Strychninum 15x. .

OTC - PURPOSE SECTION

Formulated for symptoms such as painful tendons, muscle pain or weakness, muscle spasms or difficulty in relaxing muscles.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

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
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4759-1Muscle-Tendon30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4759MUSCLE-TENDON (ACONITUM NAP., ANTIMON. TART.,ARG. NIT., ARNICA, BRYONIA, CHAMOMILLA,CHELIDONIUM MAJUS, CIMICIFUGA, EUPATORIUM PERF.,HYPERICUM, NUX VOM., RHUS TOXICODENDRON, RUTA,SARCOLACTICUM AC., STRAMONIUM, STRYCHNINUM,CHAMOMILLA, PHYTOLACCA, RUTA, SYMPHYTUM.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201205_9960c87f-f299-5d92-e053-2a95a90a7012.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-475955714-4759-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARNICA MONTANAO80TY208ZWACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
BLACK COHOSHK73E24S6X9ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
LACTIC ACID, L-F9S9FFU82NACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
STRYCHNINEH9Y79VD43JACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
COMFREY ROOTM9VVZ08EKQACTIB

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-TendonACONITUM NAP., ANTIMON. TART.,ARG. NIT., ARNICA, BRYONIA, CHAMOMILLA,CHELIDONIUM MAJUS, CIMICIFUGA, EUPATORIUM PERF.,HYPERICUM, NUX VOM., RHUS TOXICODENDRON, RUTA,SARCOLACTICUM AC., STRAMONIUM, STRYCHNINUM,CHAMOMILLA, PHYTOLACCA, RUTA, SYMPHYTUM.Newton Laboratories, Inc.9960c87f-f299-5d92-e053-2a95a90a70122020-12-04WarningsExact identifier
ndc (package): 55714-4759-1
ndc (product): 55714-4759
ndc11 (package): 55714475901
spl id: b5ab99d9-2e9f-5578-e053-2995a90a81b3
spl set id: 9960c87f-f299-5d92-e053-2a95a90a7012

Reported adverse events (FAERS/openFDA)#

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