{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Daytime and Nighttime Acetaminophen, Guaifenesin, Dextromethorphan HBr, Doxylamine Succinate Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate TITANIUM DIOXIDE SHELLAC SORBITOL SOLUTION DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GLYCERIN POVIDONE, UNSPECIFIED WATER SORBITAN D&C YELLOW NO. 10 PROPYLENE GLYCOL DOXYLAMINE SUCCINATE DOXYLAMINE POLYETHYLENE GLYCOL, UNSPECIFIED GELATIN, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN FD&C BLUE NO. 1 191 Oblong shaped capsule Daytime Acetaminophen, Guaifenesin SHELLAC WATER POVIDONE, UNSPECIFIED GELATIN, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL SOLUTION SORBITAN PROPYLENE GLYCOL FD&C BLUE NO. 1 Oblong shaped capsule 190"
      ],
      "spl_unclassified_section": [
        "Daytime Cold & Flu Softgels Drug Facts",
        "Nighttime Cold & Flu Softgels Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients (in each softgel) Acetaminophen 325mg Guaifenesin 200mg",
        "Active ingredients (in each softgels) Acetaminophen 325 mg Dextromethorphan HBr Doxylamine succinate 6.25 mg"
      ],
      "purpose": [
        "Purposes Pain reliever/fever reducer Cough suppressant",
        "Purposes Pain reliever/fever reducer Cough suppressant Antihistamine"
      ],
      "indications_and_usage": [
        "Uses Temporarily relieves these common cold and flu symptoms: - minor aches and pains - headache - sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever",
        "Uses temporarily relieves these common cold and flu symptoms: - cough - minor aches and pains - sore throat - headache - runny nose - sneezing - itching of the nose or throat - itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep headache"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount for this product 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. Ask a doctor before use if you have liver disease 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 When using this product do not use more than directed Stop use and ask a doctor if pain 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.",
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount for this product 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 glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, 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 When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain 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, 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.",
        "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 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 before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, 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",
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product do not use more than directed",
        "When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery"
      ],
      "stop_use": [
        "Stop use and ask a doctor if pain 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.",
        "Stop use and ask a doctor if pain 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, ask a health professional before use.",
        "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.",
        "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 do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and over: take 2 softgels every 4 hours children under 12 years of age: do not use",
        "Directions do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and over: take 2 softgels every 4 hours children under 12 years of age: do not use"
      ],
      "other_safety_information": [
        "Other information store at 20-25°C (68-77°F) avoid excessive heat",
        "Other information store at 20-25°C (68-77°F) avoid excessive heat"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C blue no. 1, gelatin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide",
        "Inactive ingredients D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? Call 1-877-290-4008",
        "Questions or comments? Call 1-877-290-4008"
      ],
      "package_label_principal_display_panel": [
        "CVS 916T CVS 916T 24ct"
      ],
      "set_id": "43da4211-3bb3-0a8e-e063-6294a90a4fcd",
      "id": "4d1f6ac6-844e-5f77-e063-6394a90a1812",
      "effective_time": "20260316",
      "version": "2",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Daytime and Nighttime"
        ],
        "generic_name": [
          "ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE"
        ],
        "manufacturer_name": [
          "CVS HEALTH CORP"
        ],
        "product_ndc": [
          "51316-961"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "rxcui": [
          "707195",
          "1426334",
          "2612689"
        ],
        "spl_id": [
          "4d1f6ac6-844e-5f77-e063-6394a90a1812"
        ],
        "spl_set_id": [
          "43da4211-3bb3-0a8e-e063-6294a90a4fcd"
        ],
        "package_ndc": [
          "51316-961-24"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}