{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CAFIZETAMOL FORTE Acetaminophen, Caffeine STARCH, CORN POVIDONE, UNSPECIFIED CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 6 MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE TALC STEARIC ACID D&C RED NO. 27 ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE (Caplet) 5431"
      ],
      "active_ingredient": [
        "Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg"
      ],
      "purpose": [
        "Purposes Pain reliever Pain reliever aid"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves minor aches and pain due to: headache muscular aches"
      ],
      "warnings": [
        "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 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 Caffeine warning The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist if you are taking the blood thinning drug warfarin Stop use and ask a doctor if any new symptoms occur symptoms do not get better or worsen painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days 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). Ask a doctor or pharmacist before using with other drugs if you are not sure."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have liver disease"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist if you are taking the blood thinning drug warfarin"
      ],
      "stop_use": [
        "Stop use and ask a doctor if any new symptoms occur symptoms do not get better or worsen painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 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 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": [
        "Directions do not exceed recommended dosage adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 6 caplets in 24 hours children under 12 years: ask a doctor"
      ],
      "spl_unclassified_section": [
        "Other information store at controlled room temperature 20°-25°C (68°-77°F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING"
      ],
      "inactive_ingredient": [
        "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, polyvinylpyrrolidone, stearic acid, talc, titanium dioxide."
      ],
      "questions": [
        "Questions or comments? Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel NDC 69729-147-40 CAFIZETAMOL FORTE Superior Pain, Cold & Fever Relief 40 Caplets CAFIZETAMOL"
      ],
      "set_id": "028771d3-a514-f7a5-e063-6394a90ac4f3",
      "id": "285f8d54-df38-0bbc-e063-6394a90a50bf",
      "effective_time": "20241203",
      "version": "3",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "CAFIZETAMOL FORTE"
        ],
        "generic_name": [
          "ACETAMINOPHEN, CAFFEINE"
        ],
        "manufacturer_name": [
          "OPMX LLC"
        ],
        "product_ndc": [
          "69729-147"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "CAFFEINE"
        ],
        "rxcui": [
          "307686"
        ],
        "spl_id": [
          "285f8d54-df38-0bbc-e063-6394a90a50bf"
        ],
        "spl_set_id": [
          "028771d3-a514-f7a5-e063-6394a90ac4f3"
        ],
        "package_ndc": [
          "69729-147-40"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0810053181225"
        ],
        "nui": [
          "N0000175739",
          "N0000175729",
          "N0000175790",
          "M0023046"
        ],
        "pharm_class_epc": [
          "Central Nervous System Stimulant [EPC]",
          "Methylxanthine [EPC]"
        ],
        "pharm_class_pe": [
          "Central Nervous System Stimulation [PE]"
        ],
        "pharm_class_cs": [
          "Xanthines [CS]"
        ],
        "unii": [
          "362O9ITL9D",
          "3G6A5W338E"
        ]
      }
    }
  ]
}