Label: ARNICA MONTANA tablet
- NDC Code(s): 65111-005-66
- Packager: Vitamedica Corporation
- 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 February 13, 2024
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- ACTIVE INGREDIENT:
- PURPOSE:
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WARNINGS:
If pregnant or breast-feeding ask a health professional before use. Discontinue use if any adverse reactions occur. Contact your physician, if symptoms do not subside within 14 days.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if seal is broken or shows any signs of tampering.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- USES:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE DISPLAY LABEL
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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 WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 30 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) COPOVIDONE (UNII: D9C330MD8B) 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:65111-005-66 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/13/2014 05/27/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/13/2014 05/27/2026 Labeler - Vitamedica Corporation (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)