Label: ARNICA MONTANA tablet
- NDC Code(s): 53499-3572-2, 53499-3572-3
- Packager: Schwabe North America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 28, 2020
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- Active Ingredient
- Dosage & Admininstration
- Indications & Usage
- Purpose
- Warning
- When using
- Pregnancy or breast feeding
- Keep out of reach of children
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARNICA MONTANA
arnica montana tabletProduct 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 12/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2006 12/30/2025 Labeler - Schwabe North America, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe Mexico, S.A. de C.V. 812805901 manufacture(53499-3572)