{
  "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": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Norel AD acetaminophen, chlorpheniramine maleate, and phenylephrine HCl SILICON DIOXIDE CROSPOVIDONE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K30 STARCH, CORN STEARIC ACID D&C YELLOW NO. 10 FD&C YELLOW NO. 6 ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 0425;US Arc"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other Information store at 20°-25°C (68°-77°F) Overdose Warning: Keep this and all medication out of the reach of children. In case of accidental overdose, seek medical help or contact a Poison Control Center immediately."
      ],
      "active_ingredient": [
        "Active Ingredients (per tablet) Acetaminophen 325 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg"
      ],
      "purpose": [
        "Purpose Pain reliever Antihistamine Nasal decongestant"
      ],
      "indications_and_usage": [
        "Uses Temporarily relieves these symptoms due to the common cold or flu nasal congestion runny nose minor aches and pains headache sore throat sneezing itchy, watery eyes itching of the nose or throat sinus congestion and pressure temporarily reduces fever"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 6 tablets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reaction. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, speak with a healthcare provider."
      ],
      "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 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. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking any other nasal decongestant or stimulant taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product do not exceed recommended dosage drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"
      ],
      "stop_use": [
        "Stop use and ask a doctor if pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present you get nervous, dizzy, or sleepless new symptoms occur"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast feeding ask a health professional before use"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children. Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact 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 take more than directed (see overdose warning) adults and children 12 years of age and over: take 1 tablet every 4 hours, while symptoms persist do not take more than 6 tablets in 24 hours, unless directed by a doctor children under 12 years of age: ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Colloidal Silicon Dioxide, Crospovidone Polyplasdone, Magnesium Stearate (vegetable base), Microcrystalline Cellulose, Povidone K-30, Pregelatinized Starch, Stearic Acid, D&C Yellow #10, FD&C Yellow #6."
      ],
      "questions": [
        "Questions or Comments Please visit www.uspco.com or contact us at US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Figure 1: Norel ® AD container label Norel AD container label"
      ],
      "set_id": "53d9ed3c-212d-4b12-ac35-8bd49382b49d",
      "id": "41619e00-e834-2cf6-e063-6394a90a259d",
      "effective_time": "20251017",
      "version": "14",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Norel AD"
        ],
        "generic_name": [
          "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL"
        ],
        "manufacturer_name": [
          "U.S. PHARMACEUTICAL CORPORATION"
        ],
        "product_ndc": [
          "52747-475"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "CHLORPHENIRAMINE MALEATE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1193293"
        ],
        "spl_id": [
          "41619e00-e834-2cf6-e063-6394a90a259d"
        ],
        "spl_set_id": [
          "53d9ed3c-212d-4b12-ac35-8bd49382b49d"
        ],
        "package_ndc": [
          "52747-475-70"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0352747475703"
        ],
        "unii": [
          "362O9ITL9D",
          "V1Q0O9OJ9Z",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}