ARNICA MONTANA- 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, Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:
Arnica montana 6X

INACTIVE INGREDIENT

Inactive Ingredients:

CELLULOSE, MICROCRYSTALLINE

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

CROSCARMELLOSE SODIUM

DOSAGE & ADMINISTRATION

Dosage:  

              Adults or children over 2 years: Take 3 tablets 4-6 times a day. 

              Allow to dissolve under tongue. 

INDICATIONS & USAGE

Indications:

Temporarily relieves minor muscle or joint aches and pain; strains, sprains, bruises, backache or over-exertion.

PURPOSE

Purpose: For the temporary relief of minor muscle or joint aches and pain; strains, sprains, bruises, backache or over-exertion. 

WARNINGS

Warning: Do not take 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

Pregnancy and 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:  Keep out of reach of children.

OVERDOSAGE

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

Boericke and Tafel Arnica Montana 6X  250t

INGREDIENTS AND APPEARANCE

ARNICA MONTANA  
arnica montana tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-3533
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [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: 53499-3533-2	100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2006	09/30/2019
2	NDC: 53499-3533-3	1 in 1 CARTON	01/01/2006
2		250 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

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

Labeler - Schwabe North America (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-3533)