{
  "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": "2026-06-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Relief-PE ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE STARCH, CORN STEARIC ACID CROSPOVIDONE MICROCRYSTALLINE CELLULOSE HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE AZ275"
      ],
      "active_ingredient": [
        "Active Ingredients (in each tablet): Acetaminophen 325mg Phenylephrine HCl 5mg Chlorpheniramine Maleate 2mg"
      ],
      "purpose": [
        "Purpose: Pain Reliever/Fever Reducer Antihistamine Nasal Decongestant"
      ],
      "indications_and_usage": [
        "Temporarily relieves nasal congestion, sinus pressure, and minor aches and pains due to: the common cold hay fever upper respiratory allergies headache itchy/watery eyes runny nose muscular aches Temporarily reduces fever"
      ],
      "warnings": [
        "Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take: more than 4000mg of acetaminophen 24 hours with other drugs containing acetaminophen 3 or more alcohol drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash"
      ],
      "do_not_use": [
        "Do not use: with any other drug containing acetaminophen (prescription or non-prescription) if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug, or if you do not know if your prescription drug contains an MAOI"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers you are taking the blood thinning drug warfarin you do not know if other drugs you are taking contain acetaminophen"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have heart, liver, or thyroid disease high blood pressure diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis"
      ],
      "when_using": [
        "When using this product to not use more than directed. This product may cause excitability or drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Use caution when driving a motor vehicle or operating machinery."
      ],
      "stop_use": [
        "Stop use and ask a doctor if an allergic reaction occurs, seek medical help right away you get nervous, dizzy or sleepless new symptom occur fever worsens or lasts for more than 3 days pain or nasal congestion gets worse or lasts more than 7 days redness or swelling is present These could be signs of 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."
      ],
      "overdosage": [
        "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222."
      ],
      "dosage_and_administration": [
        "Directions: Do not take more than directed . Adults and children 12 years of age an over: take 1 to 2 tablets every 6 hours while symptoms persist do not take more than 8 tablets in 24 hours unless directed by a doctor Children under 12 years of age: ask a doctor"
      ],
      "inactive_ingredient": [
        "corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelantined starch, stearic acid"
      ],
      "package_label_principal_display_panel": [
        "ReliefPEv24f.jpg"
      ],
      "set_id": "9475fb51-931b-4a89-be6b-62e715d0883e",
      "id": "129bfe8e-117e-4a42-98eb-e25990b3f2a5",
      "effective_time": "20260115",
      "version": "2",
      "openfda": {
        "application_number": [
          "M"
        ],
        "brand_name": [
          "Relief-PE"
        ],
        "generic_name": [
          "ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE"
        ],
        "manufacturer_name": [
          "HART Health"
        ],
        "product_ndc": [
          "50332-0153"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "CHLORPHENIRAMINE MALEATE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1046781"
        ],
        "spl_id": [
          "129bfe8e-117e-4a42-98eb-e25990b3f2a5"
        ],
        "spl_set_id": [
          "9475fb51-931b-4a89-be6b-62e715d0883e"
        ],
        "package_ndc": [
          "50332-0153-4",
          "50332-0153-7"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D",
          "V1Q0O9OJ9Z",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}