{
  "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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  "results": [
    {
      "spl_product_data_elements": [
        "Cold and Flu Daytime Severe, 24/7 Life acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TITANIUM DIOXIDE FD&C RED NO. 40 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE MAGNESIUM STEARATE TALC DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CROSPOVIDONE, UNSPECIFIED POVIDONE, UNSPECIFIED STEARIC ACID MICROCRYSTALLINE CELLULOSE MALTODEXTRIN GUAIFENESIN GUAIFENESIN STARCH, CORN POLYSORBATE 80 ACETAMINOPHEN ACETAMINOPHEN FD&C YELLOW NO. 6 POLYVINYL ALCOHOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO 44;640"
      ],
      "spl_unclassified_section": [
        "Drug Facts Drug Facts",
        "Other information Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number"
      ],
      "active_ingredient": [
        "Active ingredients Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg"
      ],
      "purpose": [
        "Purpose ​Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"
      ],
      "indications_and_usage": [
        "Uses Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive"
      ],
      "warnings": [
        "Warnings ​Warnings Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use Ask a doctor before use if you have liver disease thyroid disease diabetes heart disease high blood pressure difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product When using this product do not exceed recommended dosage. Stop use and ask a doctor 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 rash or headache that lasts. These could be signs of a serious condition. If pregnant 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 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. if you have ever had an allergic reaction to this product or any of its ingredients"
      ],
      "ask_doctor": [
        "Ask a doctor before use Ask a doctor before use if you have liver disease thyroid disease diabetes heart disease high blood pressure difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."
      ],
      "when_using": [
        "When using this product When using this product do not exceed recommended dosage."
      ],
      "stop_use": [
        "Stop use and ask a doctor 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 rash or headache that lasts. These could be signs of a serious condition."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant 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 Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 Directions do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Inactive ingredients corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? Questions or comments? 1-800-351-2000 (8:30 AM – 5:00 PM CST)"
      ],
      "package_label_principal_display_panel": [
        "Cold & Flu Daytime Severe, 16ct - PDP/Package Label [24/7 Life logo] Non-Drowsy [caduceus] Cold & Flu DayTime Severe Acetaminophen / Pain Reliever/Fever Reducer Dextromethorphan HBr / Cough Suppressant Guaifenesin / Expectorant Phenylephrine HCl / Nasal Decongestant Relieves: Headache, Fever, Sore Throat, Minor Aches & Pains, Chest Congestion, Nasal Congestion, Sinus Pressure, Cough compare to Vicks ® DayQuil™ SEVERE Cold & Flu active ingredients* 16 CAPLETS Actual Size [caplet image] PDP/Package"
      ],
      "set_id": "05cc7185-d49d-82a3-e063-6294a90a568e",
      "id": "296a2fbb-cb59-35a3-e063-6394a90a27be",
      "effective_time": "20241216",
      "version": "2",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Cold and Flu Daytime Severe, 24/7 Life"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET"
        ],
        "manufacturer_name": [
          "Lil' Drug Store Products, Inc."
        ],
        "product_ndc": [
          "66715-6515"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1110988"
        ],
        "spl_id": [
          "296a2fbb-cb59-35a3-e063-6394a90a27be"
        ],
        "spl_set_id": [
          "05cc7185-d49d-82a3-e063-6294a90a568e"
        ],
        "package_ndc": [
          "66715-6515-8"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "495W7451VQ",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}