{
  "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": {
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      "total": 3
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  "results": [
    {
      "spl_product_data_elements": [
        "Day Cold and Flu and Night Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl Day Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl POLYVINYL ALCOHOL, UNSPECIFIED CROSPOVIDONE FD&C YELLOW NO. 6 ALUMINUM LAKE FD&C RED NO. 40 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED TALC TITANIUM DIOXIDE SILICON DIOXIDE ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Light red to red Capsule shaped D1 Night Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl POLYVINYL ALCOHOL, UNSPECIFIED CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL, UNSPECIFIED FERRIC OXIDE YELLOW MICA MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE N1 Light golden yellow to Golden yellow Capsule shaped"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients (in each caplet) Day Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each caplet) Night Severe Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Triprolidine HCl 1.25 mg"
      ],
      "purpose": [
        "Purposes Day Cold & Flu Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant Purposes Night Severe Cold & Flu Pain reliever/fever reducer Cough suppressant Nasal decongestant Antihistamine"
      ],
      "indications_and_usage": [
        "Uses Day Cold & Flu temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache stuffy nose sinus congestion and pressure temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive Night Severe Cold & Flu temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache sneezing sinus congestion and pressure runny nose itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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 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 a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease glaucoma (Night Severe Cold & Flu only) trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis (Night Severe Cold & Flu only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Night Severe Cold & Flu only) When using this product do not use more than directed excitability may occur, especially in children (Night Severe Cold & Flu only) marked drowsiness may occur (Night Severe Cold & Flu only) alcohol, sedatives, and tranquilizers may increase drowsiness (Night Severe Cold & Flu only) avoid alcoholic drinks (Night Severe Cold & Flu only) use caution when driving a motor vehicle or operating machinery (Night Severe Cold & Flu only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts 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 fever, rash, or headache that lasts. 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. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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). 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 diabetes high blood pressure thyroid disease glaucoma (Night Severe Cold & Flu only) trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis (Night Severe Cold & Flu only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Night Severe Cold & Flu only)"
      ],
      "when_using": [
        "When using this product do not use more than directed excitability may occur, especially in children (Night Severe Cold & Flu only) marked drowsiness may occur (Night Severe Cold & Flu only) alcohol, sedatives, and tranquilizers may increase drowsiness (Night Severe Cold & Flu only) avoid alcoholic drinks (Night Severe Cold & Flu only) use caution when driving a motor vehicle or operating machinery (Night Severe Cold & Flu only)"
      ],
      "stop_use": [
        "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts 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 fever, 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. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 Day Cold & Flu do not take more than directed (see Overdose warning) do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets every 4 hours children under 12 years of age: do not use Night Severe Cold & Flu do not take more than directed (see Overdose warning) do not take more than 8 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets every 4 hours children under 12 years of age: do not use"
      ],
      "storage_and_handling": [
        "Other information store at 20-25°C (68-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Day Cold & Flu colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide Inactive ingredients Night Severe Cold & Flu colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide"
      ],
      "questions": [
        "Questions or comments? Call 1-800-910-6874"
      ],
      "package_label_principal_display_panel": [
        "daynight-ifc-40"
      ],
      "set_id": "08ee56d1-b11d-3e36-e063-6294a90acd5f",
      "id": "203f3d03-46d8-3747-e063-6294a90a251e",
      "effective_time": "20240822",
      "version": "3",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Day Cold and Flu and Night Severe Cold and Flu"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL"
        ],
        "manufacturer_name": [
          "TARGET CORPORATION"
        ],
        "product_ndc": [
          "11673-343"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "rxcui": [
          "1110988",
          "2549037",
          "2560237"
        ],
        "spl_id": [
          "203f3d03-46d8-3747-e063-6294a90a251e"
        ],
        "spl_set_id": [
          "08ee56d1-b11d-3e36-e063-6294a90acd5f"
        ],
        "package_ndc": [
          "11673-343-64"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0311673343647"
        ]
      }
    }
  ]
}