{
  "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,
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      "total": 13
    }
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  "results": [
    {
      "spl_product_data_elements": [
        "Menstrual Relief Maximum Strength Acetaminophen, Pamabrom, Pyrilamine maleate ACETAMINOPHEN ACETAMINOPHEN PAMABROM BROMOTHEOPHYLLINE PYRILAMINE MALEATE PYRILAMINE STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED FD&C BLUE NO. 2 ALUMINUM LAKE FD&C RED NO. 40 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SHELLAC SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE 44;679"
      ],
      "active_ingredient": [
        "Active ingredients (in each caplet) Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg"
      ],
      "purpose": [
        "Purpose Pain reliever Diuretic Antihistamine"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of these symptoms associated with menstrual periods: cramps headache bloating backache water-weight gain irritability muscular aches"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: 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. 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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. if you have ever had an allergic reaction to this product or any of its ingredients"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma"
      ],
      "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 drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery"
      ],
      "stop_use": [
        "Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."
      ],
      "dosage_and_administration": [
        "Directions do not take more than directed adults and children 12 years and over: take 2 caplets with water every 6 hours as needed do not exceed 6 caplets in a 24 hour period or as directed by a doctor children under 12 years: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number"
      ],
      "inactive_ingredient": [
        "Inactive ingredients corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? 1-888-423-0139"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel TopCare® health NDC 36800-979-10 COMPARE TO MAXIMUM STRENGTH PAMPRIN ® MULTI-SYMPTOM ACTIVE INGREDIENTS* MAXIMUM STRENGTH Menstrual Relief ACETAMINOPHEN - PAIN RELIEVER • PAMABROM - DIURETIC • PYRILAMINE MALEATE - ANTIHISTAMINE MULTI-SYMPTOM RELIEF OF : • Cramps • Bloating • Irritability • Headache • Backache 40 CAPLETS actual size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com QUALITY GUARANTEED *This product is not manufactured or distributed by Focus Consumer Healthcare, LLC, owner of the registered trademark Maximum Strength Pamprin® Multi-Symptom. 50844 REV0718B67910 TopCare 44-679 TopCare 44-679"
      ],
      "set_id": "18d5deea-5ddb-4c66-9e76-2fc113653357",
      "id": "d4f696fc-6759-4a8f-8101-324bf45a0bcd",
      "effective_time": "20250904",
      "version": "12",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "Menstrual Relief Maximum Strength"
        ],
        "generic_name": [
          "ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE"
        ],
        "manufacturer_name": [
          "Topco Associates, LLC"
        ],
        "product_ndc": [
          "36800-979"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "PAMABROM",
          "PYRILAMINE MALEATE"
        ],
        "rxcui": [
          "1052637"
        ],
        "spl_id": [
          "d4f696fc-6759-4a8f-8101-324bf45a0bcd"
        ],
        "spl_set_id": [
          "18d5deea-5ddb-4c66-9e76-2fc113653357"
        ],
        "package_ndc": [
          "36800-979-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0036800414617"
        ],
        "unii": [
          "362O9ITL9D",
          "UA8U0KJM72",
          "R35D29L3ZA"
        ]
      }
    }
  ]
}