{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Premsyn pms Premenstrual Pain Relief Acetaminophen and Pamabrom and Pyrilamine maleate CROSPOVIDONE MAGNESIUM STEARATE POVIDONE STEARIC ACID STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN PAMABROM BROMOTHEOPHYLLINE PYRILAMINE MALEATE PYRILAMINE P FD & C Red No. 40"
      ],
      "active_ingredient": [
        "(in each caplet) Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg"
      ],
      "purpose": [
        "Pain reliever Antihistamine Diuretic"
      ],
      "indications_and_usage": [
        "For the temporary relief of these symptoms associated with menstrual periods: cramps headache bloating backache water-weight gain muscular aches irritability"
      ],
      "warnings": [
        "Allergy Warning: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash if a skin reaction occurs stop use and seek medical help right away. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have: liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargment of the prostate gland. Ask a doctor or pharmacist before use if you are: taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product, you may get drowsy, avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving or operating machinery excitability may occur, especially in children stop use and ask doctor if: Pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present If pregnant or breastfeeding, ask a health professional before use. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product you may get drowsy, avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving or operating machinery excitability may occur, especially in children Stop use and ask a doctor if pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."
      ],
      "do_not_use": [
        "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product you may get drowsy, avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving or operating machinery excitability may occur, especially in children"
      ],
      "stop_use": [
        "Stop use and ask a doctor if pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present"
      ],
      "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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.",
        "Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."
      ],
      "dosage_and_administration": [
        "adults and children 12 years and over: take 2 caplets with water every 6 hours as needed do not exceed 8 caplets in a 24 hour period or as directed by a doctor do not use more than directed (see warnings) children under 12 years: ask a doctor"
      ],
      "inactive_ingredient": [
        "blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregalatinized starch, propylaparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide"
      ],
      "package_label_principal_display_panel": [
        "label1"
      ],
      "set_id": "5b6f6260-69ae-cfeb-e053-2a91aa0a6b49",
      "id": "32bde825-4a2d-de16-e063-6394a90a7941",
      "effective_time": "20250414",
      "version": "8",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "Premsyn pms Premenstrual Pain Relief"
        ],
        "generic_name": [
          "ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE"
        ],
        "manufacturer_name": [
          "Focus Consumer Healthcare, LLC"
        ],
        "product_ndc": [
          "71687-3102"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "PAMABROM",
          "PYRILAMINE MALEATE"
        ],
        "rxcui": [
          "1052637",
          "1052641"
        ],
        "spl_id": [
          "32bde825-4a2d-de16-e063-6394a90a7941"
        ],
        "spl_set_id": [
          "5b6f6260-69ae-cfeb-e053-2a91aa0a6b49"
        ],
        "package_ndc": [
          "71687-3102-4"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D",
          "UA8U0KJM72",
          "R35D29L3ZA"
        ]
      }
    }
  ]
}