Arnica Montana by Schwabe North America, Inc. / Schwabe Mexico, S.A. de C.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. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:
Arnica montana 30X

Inactive Ingredients:

CELLULOSE

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

SODIUM CROSCARMELLOSE

DOSAGE & ADMINISTRATION

Boericke and Tafel Brand:
Dosage:
Adults or children over 2 years:  Take 3 tablets 1-3 times a day.

Allow to dissolve under tongue.

Indications: Temporarily relieves minor muscle or joint aches and pain from strains, sprains, bruises, backache, overexertion.

Warning: Do not take this product for pain for more than 10 days for adults or 5 days for 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.

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

Purpose: For the temporary relief of minor muscle or joint aches and pain.

Boericke and Tafel BrandArnica Montana 30X  250 tablets

INGREDIENTS AND APPEARANCE

ARNICA MONTANA 
arnica montana tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-3572
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_X]

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: 53499-3572-2	100 in 1 BOTTLE, GLASS; Type 1: Convenience Kit of Co-Package	01/01/2006	03/31/2019
2	NDC: 53499-3572-3	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. de C.V.		812805901	manufacture(53499-3572)