Arnica Montana 30C: Homeopathic Product Information

ARNICA MONTANA 30C- arnica montana tablet
Schwabe Mexico, S.A. de C.V.

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.

Active Ingredient

Arnica Montana 30C

Inactive Ingredients

CELLULOSE

CROSCARMELLOSE SODIUM

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

Dosage & Administration

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

Allow to dissolve under tongue.

Indications & Usage

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

Purpose

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

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

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.

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 30C arnica montana tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68466-1041 Route of Administration SUBLINGUAL, SUBLINGUAL, SUBLINGUAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CROSCARMELLOSE SODIUM

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 Multilevel Packaging 1 NDC:68466-1041-2 1 BOTTLE, GLASS in 1 PACKAGE contains a BOTTLE, GLASS 1 250 TABLET in 1 BOTTLE, GLASS This package is contained within the PACKAGE (68466-1041-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2006 03/31/2027

Labeler — Schwabe Mexico, S.A. de C.V. (812805901)

Establishment
Name	Address	ID/FEI	Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture (68466-1041)

Revised: 05/2022 Schwabe Mexico, S.A. de C.V.