ARNICA MONTANA tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)
Available from:
Vitamedica Corporation
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-Inflammatory Temporary relief of bruising, swelling and pain.
Authorization status:
unapproved homeopathic
Authorization number:
65111-005-66

ARNICA MONTANA- arnica montana tablet

Vitamedica Corporation

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts

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

ARNICA MONTANA

arnica montana tablet

Product Information

Vitamedica Corporation

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 5111-0 0 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

30 [hp_X]

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE (UNII: J2B2A4N9 8 G)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

CO PO VIDO NE (UNII: D9 C330 MD8 B)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND (TABLET)

S iz e

6 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 5111-0 0 5-6 6

120 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/13/20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 2/13/20 14

Labeler -

Vitamedica Corporation (808198779)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo theca Co mpany

8 44330 9 15

manufacture(6 5111-0 0 5) , api manufacture(6 5111-0 0 5) , label(6 5111-0 0 5, 6 5111-0 0 5)

Revised: 4/2020

Vitamedica Corporation

Revised: 4/2020

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