FDA.reportPublic FDA data

Aches - Pains

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-11-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:35

Label at a glance#

ProductAches - Pains
Active ingredientACONITUM NAPELLUS, SILVER NITRATE, ARNICA MONTANA, BRYONIA ALBA ROOT, COLCHICUM AUTUMNALE BULB, GUAIAC, HYPERICUM PERFORATUM, KALMIA LATIFOLIA LEAF, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, LACTIC ACID, L-, LOBARIA PULMONARIA, DATURA STRAMONIUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, TARAXACUM OFFICINALE
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Aches - Pains: Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Equal parts of Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Aconitum nap. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Colchicum 15x, Guaiacum 15x, Hypericum 15x, Kalmia 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Rhus tox. 15x, Ruta 15x, Sarcolacticum ac. 15x, Sticta 15x, Stramonium 15x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

newtonlabs.net ~ Questions? 800-448-7256

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

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.

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 drop and gradually increase to full dose.

WARNINGS SECTION

Warnings: Keep our 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.

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
55714-2383-1Aches - Pains28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2383ACHES - PAINS (ACONITUM NAP., ARG. NIT., ARNICA, BRYONIA, COLCHICUM, GUAIACUM, HYPERICUM, KALMIA, PHOSPHORUS, PHYTOLACCA, PULSATILLA, RHUS TOXICODENDRON, RUTA, SARCOLACTICUM AC., STICTA, STRAMONIUM, HAMAMELIS, TARAXACUM,) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201125_7924792b-7464-576e-e053-2a91aa0abc2c.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
55714-238355714-2383-1

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
ACONITUM NAPELLUSU0NQ8555JDACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARNICA MONTANAO80TY208ZWACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
GUAIAC03C8A0DFJ8ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
KALMIA LATIFOLIA LEAF79N6542N18ACTIB
PHOSPHORUS27YLU75U4WACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
LACTIC ACID, L-F9S9FFU82NACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
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
Aches - PainsACONITUM NAP., ARG. NIT., ARNICA, BRYONIA, COLCHICUM, GUAIACUM, HYPERICUM, KALMIA, PHOSPHORUS, PHYTOLACCA, PULSATILLA, RHUS TOXICODENDRON, RUTA, SARCOLACTICUM AC., STICTA, STRAMONIUM, HAMAMELIS, TARAXACUM,Newton Laboratories, Inc.7924792b-7464-576e-e053-2a91aa0abc2c2020-11-24WarningsExact identifier
ndc (package): 55714-2383-1
ndc (product): 55714-2383
ndc11 (package): 55714238301
spl id: b4ddae41-8d61-1b6a-e053-2995a90a6247
spl set id: 7924792b-7464-576e-e053-2a91aa0abc2c

Reported adverse events (FAERS/openFDA)#

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