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 200C HPUS

Active ingredientARNICA MONTANA WHOLE

Label structure10 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

Contacts and useful links#

PhoneLabel contact888-367-8605

Websitewww.vitamedica.com

www.vitamedica.com

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 200C 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

Other 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.

QUESTIONS:

OTC - QUESTIONS SECTION

Formulated and Distributed by

VitaMedica, Inc.

Tampa, FL 33624

www.vitamedica.com

888-367-8605

customerservice@vitamedica.com

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80004-200-10

150 Count Bottle

1 Bottle Per Carton

150 Count Bottle

150 Count Bottle Carton

NDC 80004-200-20

30 Blister

1 Blister Carton

30 Count Blister

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80004-200-10	Arnica Montana200C HPUS	1 in 1 CARTON	TABLET	1	2
80004-200-10	Arnica Montana200C HPUS	150 in 1 BOTTLE	TABLET	150	2
80004-200-20	Arnica Montana200C HPUS	30 in 1 BLISTER PACK	TABLET	30	2
80004-200-20	Arnica Montana200C HPUS	1 in 1 CARTON	TABLET	1	2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Arnica Montana 200C HPUS
Arnica Montana
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SUCROSE
ARNICA MONTANA WHOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80004-200	80004-200-10, 80004-200-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SUCROSE	C151H8M554	IACT
ARNICA MONTANA WHOLE	O80TY208ZW	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arnica Montana 200C HPUS	ARNICA MONTANA	VITAMEDICA, INC.	3d6cb757-e0e7-656e-e063-6394a90a3d9e	2026-03-31	Warnings	Exact identifier ndc (package): 80004-200-20 ndc (package): 80004-200-10 ndc (product): 80004-200 ndc11 (package): 80004020020 ndc11 (package): 80004020010 spl id: 4e580d6f-4b9c-6c20-e063-6294a90a1d67 spl set id: 3d6cb757-e0e7-656e-e063-6394a90a3d9e

Reported adverse events (FAERS/openFDA)#

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