The following Structured Product Label (SPL) was submitted to the FDA by Vitamedica, Inc. for the product Arnica Montana (NDC 80004-300). 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:, other information, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Arnica Montana - Bruising, swelling, pain*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
*Temporarily relieves these symptoms:
• Bruising • Swelling • Pain • Stiff • Muscle Soreness
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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.
In case of an emergency or accidental overdose, contact a medical professional or Poison Control immediately.
• 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
• Do not use if seal is broken or shows any signs of tampering.
• Store at 68-77°F (20-25°C)
Copovidone, Crospovidone, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Silicon Dioxide, and Sorbitol.
Lactose (milk)
Formulated and Distributed by
VitaMedica, Inc.
Tampa, FL 33764
©2024 VitaMedica, Inc.
888-367-8605
www.vitamedica.com
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
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
* Please review the disclaimer below.
