{
  "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": "2026-06-09",
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  "results": [
    {
      "spl_product_data_elements": [
        "Daytime Cold and Flu Severe, Caseys 4good Acetaminophen, Phenylephrine, Dextromethorphan HBr, Guaifenesin tablet, film coated PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 TALC POLYSORBATE 80 POLYETHYLENE GLYCOL, UNSPECIFIED MALTODEXTRIN TITANIUM DIOXIDE MICROCRYSTALLINE CELLULOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CROSPOVIDONE FD&C RED NO. 40 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE ACETAMINOPHEN ACETAMINOPHEN POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE 44;640 Daytime Cold and Flu Severe, Caseys 4goog Acetaminophen, Phenylephrine, Dextromethorphan HBr, Guaifenesin tablet, film coated PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 TALC POLYSORBATE 80 POLYETHYLENE GLYCOL, UNSPECIFIED MALTODEXTRIN TITANIUM DIOXIDE MICROCRYSTALLINE CELLULOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CROSPOVIDONE FD&C RED NO. 40 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE ACETAMINOPHEN ACETAMINOPHEN POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE 44;640"
      ],
      "spl_unclassified_section": [
        "Drug Facts ​Drug Facts",
        "Other information Other information each caplet contains: sodium 3 mg 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 Alergy alert ​Alergy 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 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 if you have 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 if you are 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 if 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 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 if you have 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 if you are Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."
      ],
      "stop_use": [
        "Stop use and ask a doctor if 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 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? 1-877-507-6516 (8AM - 4:30PM CST)"
      ],
      "package_label_principal_display_panel": [
        "Daytime Cold & Flu Severe 6ct, Casey's 4good PDP/Package Compare to Vicks ® DayQuil ® VapoCOOL™ SEVERE Cold & Flu + Congestion active ingredients* SEVERE DayTime Cold & Flu Acetaminophen Pain Reliever / Fever Reducer Phenylephrine HCl Nasal Decongestant Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Relieves: Headache, Cough, Thins & Loosens Mucus, Fever, Minor Aches & Pains, Sore Throat, Chest Congestion, Sinus Pressure, Nasal Congestion [Casey's 4good TM logo] [caplet image] actual size 6 CAPLETS PDP/Package",
        "DayTime Cold & Flu, Casey's 4good™ 16ct - PDP/Package Compare to Vicks ® DayQuil ® VapoCOOL™ SEVERE Cold & Flu + Congestion active ingredients* SEVERE DayTime Cold & Flu Acetaminophen Pain Reliever / Fever Reducer Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Phenylephrine HCl Nasal Decongestant Relieves: Headache, Cough, Fever, Minor Aches & Pains, Sore Throat, Chest Congestion, Sinus Pressure, Nasal Congestion Thins & Loosens Mucus [Casey's 4goodTM logo] [caplet image] actual size 16 CAPLETS PDP/Package"
      ],
      "set_id": "0334259d-587e-b2d5-e063-6394a90a3e56",
      "id": "0a2329f9-fb21-71b2-e063-6394a90a5442",
      "effective_time": "20231114",
      "version": "2",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Daytime Cold and Flu Severe, Caseys 4goog",
          "Daytime Cold and Flu Severe, Caseys 4good"
        ],
        "generic_name": [
          "ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATED"
        ],
        "manufacturer_name": [
          "Lil' Drug Store Products, Inc."
        ],
        "product_ndc": [
          "66715-6304",
          "66715-6315"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1110988"
        ],
        "spl_id": [
          "0a2329f9-fb21-71b2-e063-6394a90a5442"
        ],
        "spl_set_id": [
          "0334259d-587e-b2d5-e063-6394a90a3e56"
        ],
        "package_ndc": [
          "66715-6315-8",
          "66715-6304-3"
        ],
        "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",
          "04JA59TNSJ",
          "495W7451VQ"
        ]
      }
    }
  ]
}