Drug Facts:

Drug Facts:
SPL v9
SPL
SPL Set ID 40836bb5-a4a8-4fba-82ea-f9aa41cba4e6
Route
ORAL
Published
Effective Date 2025-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (30 [hp_X])
Inactive Ingredients
Copovidone K25-31 Crospovidone Lactose, Unspecified Form Magnesium Stearate Mannitol Microcrystalline Cellulose Silicon Dioxide Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: V Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-05-18

Description

Arnica Montana 30X HPUS.** **The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States. 

Purpose

Arnica Montana - Bruising, swelling, pain* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Arnica Montana - Bruising, swelling, pain* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Arnica Montana 30X HPUS.** **The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States. 

Uses:

*Temporarily relieves these symptoms:

• Bruising • Swelling • Pain • Stiffness • Muscle Soreness

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

Purpose:

Arnica Montana - Bruising, swelling, pain*

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

Warnings:

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

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.

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

• Store at 68-77°F (20-25°C)

Questions:

Formulated & Distributed by

VitaMedica, Inc. 

Tampa, FL 33624

888-367-8605

www.vitamedica.com

[email protected]

©2025 VitaMedica, Inc.

Directions:

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

Adults and children 12 years and over - Take 2 tablets, 3 times a day

Children under 12 years - Not intended

Active Ingredient:

Arnica Montana 30X HPUS.**

**The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States. 

Inactive Ingredients:

Copovidone, crospovidone, lactose, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, and sorbitol.

Package Label Display:

VitaMedica

Arnica 

Montana

30X HPUS

Natural Remedy

Stimulates Healing*

Naturally Reduces

• Pain*

• Bruising*

• Swelling*

30 Quick Dissolving

Tablets

Homeopathic Medicine

Keep Out of Reach of Children:

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


Structured Label Content

Uses: (USES:)

*Temporarily relieves these symptoms:

• Bruising • Swelling • Pain • Stiffness • Muscle Soreness

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

Purpose: (PURPOSE:)

Arnica Montana - Bruising, swelling, pain*

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

Warnings: (WARNINGS:)

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

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.

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

• Store at 68-77°F (20-25°C)

Questions: (QUESTIONS:)

Formulated & Distributed by

VitaMedica, Inc. 

Tampa, FL 33624

888-367-8605

www.vitamedica.com

[email protected]

©2025 VitaMedica, Inc.

Directions: (DIRECTIONS:)

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

Adults and children 12 years and over - Take 2 tablets, 3 times a day

Children under 12 years - Not intended

Active Ingredient: (ACTIVE INGREDIENT:)

Arnica Montana 30X HPUS.**

**The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States. 

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Copovidone, crospovidone, lactose, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, and sorbitol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

VitaMedica

Arnica 

Montana

30X HPUS

Natural Remedy

Stimulates Healing*

Naturally Reduces

• Pain*

• Bruising*

• Swelling*

30 Quick Dissolving

Tablets

Homeopathic Medicine

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

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


Advanced Ingredient Data


Raw Label Data

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