{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 68
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Arnicare Leg Cramps ARNICA MONTANA WHOLE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA TOP, CLAVICEPS PURPUREA SCLEROTIUM PASSIFLORA INCARNATA TOP PASSIFLORA INCARNATA TOP MAGNESIUM STEARATE CROSCARMELLOSE SODIUM COPPER COPPER LACTOSE, UNSPECIFIED FORM ARNICA MONTANA ARNICA MONTANA MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM Boiron"
      ],
      "active_ingredient": [
        "Active ingredients** (in each tablet) Arnica montana 6C HPUS (0.42 mg) Cuprum metallicum 4C HPUS (0.42 mg) Magnesia phosphorica 6C HPUS (0.42 mg) Nux vomica 6C HPUS (0.42 mg) (contains less than 10 -13 mg strychnine alkaloids) Passiflora incarnata 3X HPUS (0.42 mg) Secale cornutum 9C HPUS (0.42 mg) (contains less thank 10 -20 mg ergotamine alkaloids) The letters \"HPUS\" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States."
      ],
      "purpose": [
        "Purpose* Arnica montana 6C HPUS ... Temporarily relieves minor muscle pain Cuprum metallicum 4C HPUS ... Relieves sudden muscle cramps in the legs, calves, feet, and toes Magnesia phosphorica 6C HPUS ... Relieves flashing pain and cramps in the calves and thighs, at night Nux vomica 6C HPUS ... Relieves cramps in the legs, thighs, calves and toes, at night Passiflora incarnata 3X HPUS ... Helps to fall back asleep Secale cornutum 9C HPUS ... Relieves leg cramps at night"
      ],
      "indications_and_usage": [
        "Uses* temporarily relieves nighttime cramps in legs, thighs, calves, feet, and toes with accompanying occasional disrupted sleep"
      ],
      "warnings": [
        ""
      ],
      "stop_use": [
        "Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition."
      ],
      "pregnancy_or_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. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Adults and children 18 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth at bedtime and during the night if needed, for up to 6 times per 24 hours. Children under 18 years of age: Not recommended."
      ],
      "inactive_ingredient": [
        "croscarmellose sodium, lactose, magnesium stearate"
      ],
      "questions": [
        "Questions or comments? Arnicare.com BoironUSA.com Info@Boiron.com 1-800-BOIRON-1 (1-800-264-7661) Made in France Distributed by Boiron, Inc. Newtown Square, PA 19073"
      ],
      "spl_unclassified_section": [
        "do not use if glued carton end flaps are open or if the blister seal is broken store below 86 o F (30 o C) 60 Meltaway Tablets, unflavored 120 Meltaway Tablets, unflavored Nighttime Leg Cramp Relief* Plant-Based & Other Pure Actives Non-Habit Forming No Known Drug Interactions No Artificial Sweeteners, Flavors, Colors or Preservatives *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details."
      ],
      "package_label_principal_display_panel": [
        "label label label label label label"
      ],
      "set_id": "051a4e17-c665-ec4d-e063-6294a90aabe6",
      "id": "1c320dfd-afb8-9ac2-e063-6394a90a397e",
      "effective_time": "20240701",
      "version": "3",
      "openfda": {
        "brand_name": [
          "Arnicare Leg Cramps"
        ],
        "generic_name": [
          "ARNICA MONTANA WHOLE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA TOP, CLAVICEPS PURPUREA SCLEROTIUM"
        ],
        "manufacturer_name": [
          "Laboratoires Boiron"
        ],
        "product_ndc": [
          "0220-9079"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ARNICA MONTANA",
          "CLAVICEPS PURPUREA SCLEROTIUM",
          "COPPER",
          "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
          "PASSIFLORA INCARNATA TOP",
          "STRYCHNOS NUX-VOMICA SEED"
        ],
        "spl_id": [
          "1c320dfd-afb8-9ac2-e063-6394a90a397e"
        ],
        "spl_set_id": [
          "051a4e17-c665-ec4d-e063-6294a90aabe6"
        ],
        "package_ndc": [
          "0220-9079-04",
          "0220-9079-29"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0005152",
          "N0000175831",
          "N0000008595",
          "N0000008924",
          "N0000175830",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0000728",
          "M0016962",
          "M0516536"
        ],
        "pharm_class_cs": [
          "Copper [CS]",
          "Allergens [CS]",
          "Plant Proteins [CS]",
          "Seed Storage Proteins [CS]"
        ],
        "pharm_class_epc": [
          "Copper-containing Intrauterine Device [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Embryonic Implantation [PE]",
          "Decreased Sperm Motility [PE]",
          "Inhibit Ovum Fertilization [PE]",
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "unii": [
          "O80TY208ZW",
          "01G9XEA93N",
          "789U1901C5",
          "HF539G9L3Q",
          "CLF5YFS11O",
          "269XH13919"
        ]
      }
    }
  ]
}