{
  "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": [
        "MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HBr 10 mg PHENYLEPHRINE HCI 5 mg SORBITOL PROPYLENE GLYCOL SHELLAC GLYCERIN FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE WATER PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 70 OBLONG SHAPED"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS",
        "OTHER INFORMATION Other information store at room temperature"
      ],
      "active_ingredient": [
        "Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"
      ],
      "purpose": [
        "Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels in 24 hours, which is the maximum daily amount for this product 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. 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, consult a doctor promptly."
      ],
      "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 trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."
      ],
      "when_using": [
        "When using this product, do not use more than directed."
      ],
      "stop_use": [
        "Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough get worse or last more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. 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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms."
      ],
      "dosage_and_administration": [
        "Directions take only as directed do not exceed 4 doses per 24 hours adults & children 12 yrs & over: 2 softgels with water every 4 hrs children 4 to under 12 yrs:ask a doctor children under 4 yrs:do not use"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C red#40, FD&C yellow#6, gelatin, glycerin,polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide"
      ],
      "questions": [
        "Questions? call 1-877-290-4008"
      ],
      "package_label_principal_display_panel": [
        "daytime-cold-flu-48s-ifc daytime-24s-carton"
      ],
      "set_id": "c92dbbbb-d149-1e7e-e053-2a95a90a6f1a",
      "id": "164a1b51-e8d2-e907-e063-6394a90a6ad1",
      "effective_time": "20240417",
      "version": "3",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME"
        ],
        "generic_name": [
          "ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG"
        ],
        "manufacturer_name": [
          "RITE AID"
        ],
        "product_ndc": [
          "11822-1989"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1086997"
        ],
        "spl_id": [
          "164a1b51-e8d2-e907-e063-6394a90a6ad1"
        ],
        "spl_set_id": [
          "c92dbbbb-d149-1e7e-e053-2a95a90a6f1a"
        ],
        "package_ndc": [
          "11822-1989-0",
          "11822-1989-9"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0011822198806"
        ],
        "unii": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}