ARNICA MONTANA - arnica montana tablet 
Schwabe North America

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 6X

Active Ingredient

Arnica montana 6X

Inactive Ingredient

CELLULOSE

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

SODIUM CROSCARMELLOSE

Dosage & Administration

Dosage:  

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

              Allow to dissolve under tongue. 

Indications 

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

Purpose

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

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

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 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.

Overdosage

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

Arnica montana 6X-21103534_5.jpg

ARNICA MONTANA  
arnica montana tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-3533
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [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:53499-3533-2100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/200609/30/2019
2NDC:53499-3533-31 in 1 CARTON01/01/200610/31/2025
2250 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/200610/31/2025
Labeler - Schwabe North America (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-3533)

Revised: 10/2020
Document Id: a1540a26-52e7-4f53-896a-10858c0102b2
Set id: 670f4cf3-e59f-4927-8257-23befc539281
Version: 8
Effective Time: 20201012
 
Schwabe North America