{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Cyclease PMS ESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE CROSCARMELLOSE SODIUM LACTOSE MAGNESIUM STEARATE ESTRONE ESTRONE SODIUM CHLORIDE SODIUM CATION SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE BOIRON ;"
      ],
      "active_ingredient": [
        "Folliculinum 15C HPUS (0.8mg), Natrum muriaticum 12C HPUS (0.8mg), Sepia 12C HPUS (0.8mg)"
      ],
      "indications_and_usage": [
        "Temporary relieves premenstrual symptoms such as: bloating, water retention, minor aches, lower back pain, discomfort, emotional changes, irritability"
      ],
      "do_not_use": [
        "Do not use if glued carton end flaps are open or if the blister seal is broken"
      ],
      "dosage_and_administration": [
        "Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth morning and evening until symptoms are relieved. Children under 12 years of age: Not recommended"
      ],
      "inactive_ingredient": [
        "Croscarmellose sodium, lactose, magnesium stearate"
      ],
      "how_supplied": [
        "60 meltaway tablets"
      ],
      "purpose": [
        "Folliculinum 15C ...Relieves discomfort and aches associated with PMS Natrum muriaticum 12C ...Relieves water retention and irritability Sepia 12C...Relieves bloating and lower back pain."
      ],
      "storage_and_handling": [
        "Store at 68-77 o F (30 o C)"
      ],
      "questions": [
        "Questions, Comments Boironusa.com info@boironusa.com 1-800-BOIRON-1 (1-800-264-7661) Distributed by Boiron, Inc. Newtown Square, PA 19073"
      ],
      "ask_doctor": [
        ""
      ],
      "stop_use": [
        "Stop use and ask a doctor if symptoms persist for more than 7 days or worsen."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center right away."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "when_using": [
        ""
      ],
      "drug_interactions": [
        "Safe - no side effects - no drug interactions - works naturally with your body"
      ],
      "warnings": [
        "Enter section text here"
      ],
      "spl_unclassified_section": [
        "The letters \"HPUS\" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. *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 box"
      ],
      "set_id": "09ff0633-2992-4aba-96ed-45a69f3ee589",
      "id": "fcea41e7-b1a6-8718-e053-6294a90a117a",
      "effective_time": "20230530",
      "version": "6",
      "openfda": {
        "brand_name": [
          "Cyclease PMS"
        ],
        "generic_name": [
          "ESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE"
        ],
        "manufacturer_name": [
          "Laboratoires Boiron"
        ],
        "product_ndc": [
          "0220-9081"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESTRONE",
          "SEPIA OFFICINALIS JUICE",
          "SODIUM CHLORIDE"
        ],
        "spl_id": [
          "fcea41e7-b1a6-8718-e053-6294a90a117a"
        ],
        "spl_set_id": [
          "09ff0633-2992-4aba-96ed-45a69f3ee589"
        ],
        "package_ndc": [
          "0220-9081-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "2DI9HA706A",
          "QDL83WN8C2",
          "451W47IQ8X"
        ]
      }
    }
  ]
}