Label: ARNICA MONTANA tablet
- NDC Code(s): 65111-005-77
- Packager: VITAMEDICA 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 May 18, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT:
- PURPOSE:
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WARNINGS:
Ask a doctor before use if pregnant or breastfeeding.
Stop use and ask a doctor if
• Any adverse reactions occur
• Symptoms persist for more than 14-days or worsen
Keep this and all medications out of reach of children.
In case of an emergency or accidental overdose, contact a medical professional or Poison Control Center immediately.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ARNICA MONTANA
arnica montana tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65111-005 Route of Administration ORAL 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 SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) COPOVIDONE (UNII: D9C330MD8B) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape ROUND (TABLET) Size 6mm Flavor Imprint Code V Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65111-005-77 1 in 1 CARTON 11/17/2014 09/08/2026 1 30 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/17/2014 09/08/2026 Labeler - VITAMEDICA INC (808198779) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(65111-005) , api manufacture(65111-005) , label(65111-005) , pack(65111-005)
