Arnica Montana 30c Hpus

Arnica Montana 30c Hpus
SPL v1
SPL
SPL Set ID 3d6bfff9-16a2-8ff8-e063-6394a90a2bda
Route
ORAL
Published
Effective Date 2024-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Whole (30 [hp_C])
Inactive Ingredients
Copovidone K25-31 Crospovidone Lactose Monohydrate Magnesium Stearate Mannitol Microcrystalline Cellulose Silicon Dioxide Sorbitol

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-03-14

Description

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.


Medication Information

Purpose

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

Description

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.

Uses:

*Temporarily relieves these symptoms:

• Bruising • Swelling • Pain • Stiff • Muscle Soreness 

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

Contains

Lactose (milk)

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

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.

Questions:

Formulated and Distributed by

VitaMedica, Inc.

Tampa, FL 33764

©2024 VitaMedica, Inc.

888-367-8605

www.vitamedica.com

[email protected]

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

Other Information

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

• Store at 68-77°F (20-25°C)

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.

Inactive Ingredients:

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

Package Display 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

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

Keep Out of Reach of Children:

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


Structured Label Content

Uses: (USES:)

*Temporarily relieves these symptoms:

• Bruising • Swelling • Pain • Stiff • Muscle Soreness 

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

Contains (CONTAINS)

Lactose (milk)

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

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.

Questions: (QUESTIONS:)

Formulated and Distributed by

VitaMedica, Inc.

Tampa, FL 33764

©2024 VitaMedica, Inc.

888-367-8605

www.vitamedica.com

[email protected]

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 3 tablets, 3 times a day

Children under 12 years - Not intended

Other Information

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

• Store at 68-77°F (20-25°C)

Active Ingredient: (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.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

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

Package Display Label (PACKAGE DISPLAY 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

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

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 immediately.


Advanced Ingredient Data


Raw Label Data

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