Arnica Montana

Manufacturer
VITAMEDICA, INC.
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:38:15

Label at a glance#

ProductArnica Montana 30C HPUS
Active ingredientARNICA MONTANA WHOLE
Label structure11 sections

Indications and uses

*Temporarily relieves these symptoms: • Bruising • Swelling • Pain • Stiff • Muscle Soreness  *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• Do not handle the tablets. Instead, drop tablets directly under the tongue and let dissolve naturally. Adults and children 12 years and over - Take 3 tablets, 3 times a day Children under 12 years - Not intended

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 30C HPUS.**

**The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States. This product has been manufactured at an FDA-regulated facility.

PURPOSE:

OTC - PURPOSE SECTION

Arnica Montana - Bruising, swelling, pain*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

*Temporarily relieves these symptoms:

• Bruising • Swelling • Pain • Stiff • Muscle Soreness 

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

Ask a doctor before use if pregnant or breastfeeding.

Stop use or consult a physician if

• Any adverse reactions occur

• Symptoms persist for more than 14-days or worsen

Discontinue use if any adverse reactions occur.

Keep this and all medications out of reach of children.

In case of an emergency or accidental overdose, contact a medical professional or Poison Control immediately.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of an emergency or accidental overdose, contact a medical professional or Poison Control immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Do not handle the tablets. Instead, drop tablets directly under the tongue and let dissolve naturally.

Adults and children 12 years and over - Take 3 tablets, 3 times a day

Children under 12 years - Not intended

Other Information

OTHER SAFETY INFORMATION

• Do not use if seal is broken or shows any signs of tampering.

• Store at 68-77°F (20-25°C)

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Copovidone, Crospovidone, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Silicon Dioxide, and Sorbitol.

CONTAINS

OTHER SAFETY INFORMATION

Lactose (milk)

QUESTIONS:

OTC - QUESTIONS SECTION

Formulated and Distributed by

VitaMedica, Inc.

Tampa, FL 33764

©2024 VitaMedica, Inc.

888-367-8605

www.vitamedica.com

customerservice@vitamedica.com

PACKAGE DISPLAY LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VitaMedica

Arnica Montana

30C HPUS•

Natural remedy Stimulates Healing*

Naturally Reduces

•Bruising*

•Muscle soreness *

•Muscle stiffness *

150 Tablets

Homeopathic Medicine

NDC 80004-300-10

150 Count Bottle

1 Bottle Per carton

Bottle CartonBottle CartonBottle LabelBottle Label

VitaMedica

Arnica Montana

30C HPUS•

Natural remedy Stimulates Healing*

Naturally Reduces

•Bruising*

•Muscle soreness *

•Muscle stiffness *

150 Tablets

Homeopathic Medicine

NDC 80004-300-10

30 Count Blister

1 Blister Per carton

Blister CartonBlister Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80004-300-10Arnica Montana30C HPUS1 in 1 CARTONTABLET12
80004-300-10Arnica Montana30C HPUS150 in 1 BOTTLETABLET1502
80004-300-20Arnica Montana30C HPUS30 in 1 BLISTER PACKTABLET302
80004-300-20Arnica Montana30C HPUS1 in 1 CARTONTABLET12

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80004-30080004-300-10, 80004-300-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
Arnica Montana 30C HPUSARNICA MONTANAVITAMEDICA, INC.3d6bfff9-16a2-8ff8-e063-6394a90a2bda2026-03-31WarningsExact identifier
ndc (package): 80004-300-20
ndc (package): 80004-300-10
ndc (product): 80004-300
ndc11 (package): 80004030010
ndc11 (package): 80004030020
spl id: 4e580e93-09b7-ad67-e063-6394a90aea01
spl set id: 3d6bfff9-16a2-8ff8-e063-6394a90a2bda

Reported adverse events (FAERS/openFDA)#

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