Arnica Montana 30c Hpus Tablet
FDA Label NDC 80004-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vitamedica, Inc. for the product Arnica Montana 30c Hpus (NDC 80004-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

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:

Arnica Montana - Bruising, swelling, pain*

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

Uses:

*Temporarily relieves these symptoms:

• Bruising • Swelling • Pain • Stiffness • Muscle Soreness

*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.

CONTAINS: Lactose (milk)

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

• Store at 68-77°F (20-25°C)

Keep Out Of Reach Of Children:

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

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 3 tablets, 3 times a day

Children under 12 years - Not intended

Inactive Ingredients:

Croscarmellose Sodium, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Sucrose.

Questions:

Formulated and Distributed by

VitaMedica, Inc.

Tampa, Fl 33624

©2025 VitaMedica, Inc.

888-367-8605

www.vitamedica.com/[email protected]

Package Display Label

VitaMedica

Arnica Montana

30C HPUS

Strong Potency

Reduces

• Pain*

• Bruising*

• Swelling*

Natural Remedy Stimulates Healing

150 Tablets

Homeopathic Medicine

* Please review the disclaimer below.