{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Pamabrom Pamabrom GELATIN GLYCERIN SORBITOL PAMABROM BROMOTHEOPHYLLINE WATER FD&C BLUE NO. 1 POVIDONE K30 POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL transparent"
      ],
      "active_ingredient": [
        "Active ingredient (in each softgel capsule) Pamabrom USP 50 mg"
      ],
      "purpose": [
        "Purpose Diuretic"
      ],
      "indications_and_usage": [
        "Uses For the relief of temporary water weight gain bloating swelling full feeling associated with the premenstrual and menstrual periods."
      ],
      "warnings": [
        "Ask a doctor or pharmacist before use if you are taking any other medication."
      ],
      "do_not_use": [
        "Stop use and ask a doctor if symptoms last for more than ten consecutive days."
      ],
      "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 chlidren In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Read all package directions and warnings before use. Use only as directed. Adults: One (1) softgel capsule after breakfast with a full glass of water, Dose may be repeated after 6 hours, not to exceed four (4) softgel capsules per day. Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period. Drink 6 to 8 glasses of water daily. For use by normally healthy adults only. Persons under 18 years of age should use only as directed by a doctor."
      ],
      "storage_and_handling": [
        "Other information Contents sealed: Blue transparent, oval shaped softgel capsules filled with clear to pale blue liquid. Contents packaged in a bottle with a safety seal under cap. Do not use if seal appears broken."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Povidone K30, Propylene glycol, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD&C Blue No.1 and Purified water."
      ],
      "package_label_principal_display_panel": [
        "Bottle Label"
      ],
      "set_id": "186805ed-84fc-e723-e063-6294a90ad320",
      "id": "4958ad4c-0499-11f0-e063-6394a90a81d1",
      "effective_time": "20260127",
      "version": "2",
      "openfda": {
        "application_number": [
          "M027"
        ],
        "brand_name": [
          "Pamabrom"
        ],
        "generic_name": [
          "PAMABROM"
        ],
        "manufacturer_name": [
          "Softgel Healthcare Pvt Ltd"
        ],
        "product_ndc": [
          "35916-1654"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PAMABROM"
        ],
        "rxcui": [
          "832080"
        ],
        "spl_id": [
          "4958ad4c-0499-11f0-e063-6394a90a81d1"
        ],
        "spl_set_id": [
          "186805ed-84fc-e723-e063-6294a90ad320"
        ],
        "package_ndc": [
          "35916-1654-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0335916165414"
        ],
        "unii": [
          "UA8U0KJM72"
        ]
      }
    }
  ]
}