Arnica Montana by Schwabe North America, Inc. / Schwabe Mexico, S.A. deC.V. ARNICA MONTANA tablet

Arnica Montana by

Drug Labeling and Warnings

Arnica Montana by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc., Schwabe Mexico, S.A. deC.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Arnica Montana 30C

Inactive Ingredients:

CELLULOSE

CROSCARMELLOSE SODIUM

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

DOSAGE & ADMINISTRATION

Dosage and Administration:

Boericke and Tafel Brand

Directions: Adults or children over 2 years:  Take 3 tablets 1-3 times a day.

Allow to dissolve under tongue. 

Indications and Usage: 

Temporarily relieves minor muscle or joint aches and pans from strains, sprains, bruises, bachache, over extertion.

Purpose:

For the temporary relief of minor muscle or joint aches and pains from strains, sprains, bruises, backache and over exertion.

WARNINGS

Warnings:

Do not use this product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor. 

When using this product, if pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.

Pregnancy or Breast Feeding:

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

Keep Out of Reach of Children:

Keep out of reach of children.

ASK DOCTOR

Ask the Doctor:

Do not take product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor. 

If pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.

OVERDOSAGE

Overdosage:

In case of overdose, seek medical help or contact a Poison Control Center immediately.

21203574_Arnia montana-30C_05

INGREDIENTS AND APPEARANCE

ARNICA MONTANA 
arnica montana tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-3571
Route of Administration	SUBLINGUAL

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

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white (white tablet)	Score	no score
Shape	ROUND (B&T)	Size	6mm
Flavor		Imprint Code	B;T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-3571-2	100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2006	10/31/2018
2	NDC: 53499-3571-3	250 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2006

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. deC.V.		812805901	manufacture(53499-3571)