Arnica Montana by Vitamedica Corporation / Apotheca Company ARNICA MONTANA tablet

Arnica Montana by

Drug Labeling and Warnings

Arnica Montana by is a Homeopathic medication manufactured, distributed, or labeled by Vitamedica Corporation, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT:

Arnica montana 30X.

PURPOSE:

Anti-Inflammatory

WARNINGS:

If pregnant or breast-feeding ask a health professional before use.  Discontinue use if any adverse reactions occur.  Contact your physician, if symptoms do not subside within 14 days.

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

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

KEEP OUT OF REACH OF CHILDREN:

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults:  Three tablets, Three times a day.  Not intended for children under 12 years of age.  This product is a sublingual application.

USES:

Temporary relief of bruising, swelling and pain.

INACTIVE INGREDIENTS:

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

QUESTIONS:

Formulated and Distributed

by VitaMedica Corp.,

Torrance, CA 90502

888-367-8605 

www.vitamedica.com l www.vitamedica.com

©2020 VitaMedica Corporation

PACKAGE DISPLAY LABEL

NDC: 65111-005-66

VitaMedica

Arnica

Montana 30X HPUS

HOMEOPATHIC MEDICINE

To Reduce Bruising, Swelling &

Pain from Soft Tissue Injury

120 Tablets

INGREDIENTS AND APPEARANCE

ARNICA MONTANA 
arnica montana tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65111-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
COPOVIDONE (UNII: D9C330MD8B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (TABLET)	Size	6mm
Flavor		Imprint Code	V
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65111-005-66	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/13/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/13/2014

Labeler - Vitamedica Corporation (808198779)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(65111-005) , api manufacture(65111-005) , label(65111-005, 65111-005)