ARNICA MONTANA- arnica montana tablet 
Schwabe North America, Inc.

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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Arnica Montana 30X

Active Ingredient

Arnica montana 30X

Inactive Ingredients

CELLULOSE

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

SODIUM CROSCARMELLOSE

Dosage & Admininstration 

Adults or children over 2 years:  Take 3 tablets 1 to 3 times per day.

Allow to dissolve under tongue.

Indications & Usage

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

Purpose

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

Warning

Do not use this product for pain for more than 10 days for adults and 5 days for children unless directed by a doctor.

When using 

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 serious conditions. 

Pregnancy or breast feeding

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

Keep out of reach of children

Keep out of reach of children.

Overdose

In case of overdoese, seek medical help or contact a Posion Control Center immediately. 

Arnica Montana_30X_21103574_04.jpg

ARNICA MONTANA 
arnica montana tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-3572
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
Colorwhite (white tablet) Scoreno score
ShapeROUND (B&T) Size6mm
FlavorImprint Code B;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-3572-2100 in 1 BOTTLE, GLASS; Type 1: Convenience Kit of Co-Package01/01/200603/31/2019
2NDC:53499-3572-3250 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/200612/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/200612/30/2025
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-3572)

Revised: 12/2020
Document Id: 68443f27-ae8b-4cea-824f-3803cb386feb
Set id: 7cef8581-97a6-44d3-af10-5b9067f022c1
Version: 9
Effective Time: 20201228
 
Schwabe North America, Inc.