ARNICA MONTANA by VITAMEDICA INC / 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 INC, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT:

Arnica Montana 30X.

PURPOSE:

Anti-Inflammatory

Uses

For temporary relief of bruising, swelling and pain associated with soft tissue injury.

WARNINGS:

Stop use and ask a doctor if

Any adverse reactions occur

Symptoms do not subside within 14 days

If pregnant or breast-feeding ask a health professional before use.

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: 2 tablets, 3 times a day.

Not intended for children under 12 years of age.

This product is a sublingual application.

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

INDICATIONS:

Anti-Inflammatory

Uses

For temporary relief of bruising, swelling and pain associated with soft tissue injury.

INACTIVE INGREDIENTS:

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

QUESTIONS:

Formulated and Distributed by

VitaMedica Corporation

Torrance, CA 90502

Toll free 888-367-8605

PACKAGE LABEL DISPLAY:

NDC: 65111-005-77

VitaMedica

The Science of Natural Health

          Arnica

Montana 30X HPUS

HOMEOPATHIC MEDICINE

To Reduce Bruising, Swelling &

Pain from Soft Tissue Injury

A RECOVERY

30 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
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
COPOVIDONE (UNII: D9C330MD8B)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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: 65111-005-77	1 in 1 CARTON	11/17/2014
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/17/2014

Labeler - VITAMEDICA INC (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) , pack(65111-005)