{
  "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",
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  "results": [
    {
      "spl_product_data_elements": [
        "Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI, Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 PROPYLENE GLYCOL WATER FD&C RED NO. 40 ANHYDROUS CITRIC ACID EDETATE CALCIUM DISODIUM SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE GLYCERIN PROPYL GALLATE SORBITOL SUCRALOSE XANTHAN GUM Nighttime Cold and Flu Maximum Strength Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GLYCERIN PROPYLENE GLYCOL WATER SORBITOL ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 SODIUM BENZOATE SODIUM CITRATE SUCRALOSE PROPYL GALLATE XANTHAN GUM EDETATE CALCIUM DISODIUM"
      ],
      "active_ingredient": [
        "Active ingredients for Nighttime (in each 20 mL) Acetaminophen 650 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 10 mg",
        "Active ingredients for Daytime (in each 20 mL) Dextromethorphan HBr 20 mg Guaifeenesin 400 mg Phenylephrine HCl 10 mg"
      ],
      "purpose": [
        "Purpose for Nighttime Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant",
        "Purpose for Daytime Cough suppressant Expectorant Nasal decongestant"
      ],
      "indications_and_usage": [
        "Uses Nighttime temporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep Daytime helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold"
      ],
      "warnings": [
        "Warnings NIGHTTIME Liver warnin g: This product contain 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: 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 Nighttime with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on the skin 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 for children under 12 years of age Daytime for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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 Nighttime liver disease heart disease high blood pressure thyroid disease diabetes 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, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Daytime heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are Nighttime you are taking the blood thinning drug warfarin you are taking sedative or tranquilizers When using these products Nighttime 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 be careful when driving a motor vehicile or operating machinery Daytime do not use more than directed Stop use and ask a doctor if Nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last 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 a signs of a serious condition Daytime nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, Nighttime and DayTime ask a health professional before use. Keep out of reach of children. Nighttime 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. DayTime In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use Nighttime with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on the skin 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 for children under 12 years of age Daytime for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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 Nighttime liver disease heart disease high blood pressure thyroid disease diabetes 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, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Daytime heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema cough that occurs with too much phlegm (mucus)"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are Nighttime you are taking the blood thinning drug warfarin you are taking sedative or tranquilizers"
      ],
      "when_using": [
        "When using these products Nighttime 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 be careful when driving a motor vehicile or operating machinery Daytime do not use more than directed"
      ],
      "stop_use": [
        "Stop use and ask a doctor if Nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last 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 a signs of a serious condition Daytime nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever 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, Nighttime and DayTime ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. Nighttime 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. DayTime In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions Nighttime do not take more than directed (see overdose warning ) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = mililiter dose as follows or as directed by a doctor adults and children 12 years and older: 20 mL every 4 hours while symptoms last children under 12 years of age: do not use Daytime do not take more than 6 doses in any 24-hours period measure only with dosing cup provided. Do not use any other dosing device. shake well before using keep dosing cup with product mL = milliliter adults and children 12 years of age and older: 20 mL every 4 hours children under 12 years of age: do not use"
      ],
      "storage_and_handling": [
        "Other information Nighttime each 20 mL contains : sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate. Daytime each 20 mL contains : 17 mg store between 20-25ºC (68-77ºF). Do not refrigerate."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Nighttime citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum Daytime citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum"
      ],
      "questions": [
        "Questions or comments? Nighttime and DayTime Call 1-888-309-9030"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Compare to the active ingredients of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough & Night Time Cold & Flu* NIGHTTIME Maximum Strength Fast Acting Night Time Cold & Flu Multi-Symptom Relief Acetaminophen DiphenhydramineHCI Phenylephrine HCI Pain Reliever/Fever reducer Antihistamine/Cough Suppressant Nasal Decongestant For ages 12 years and over DAYTIME Maximum Strength Fast Acting Mucus Relief Severe Congestion & Cough Multi-Symptom Relief Dextromethorphan HBr Guaifenesin Phenylephrine HCI Cough Suppressant Expectorant Nasal Decongestant For ages 12 years and over TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. ↑↑This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Severe Congestion & Cough and Nighttime Cold & Flu. DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072",
        "Product Label DOLLAR GENERAL HEALTH Maximum Strength Mucus Relief Severe Congestion and Cough, Cold Flu Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg, Acetaminophen 650 mg, Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg"
      ],
      "set_id": "0d65c4a9-938c-4a89-b1f1-d9ada8a8c587",
      "id": "2ef0bda0-f49e-4e10-84d5-ec4a368003fb",
      "effective_time": "20231010",
      "version": "7",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI"
        ],
        "manufacturer_name": [
          "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)"
        ],
        "product_ndc": [
          "55910-562"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "1043543",
          "1375932",
          "2637728"
        ],
        "spl_id": [
          "2ef0bda0-f49e-4e10-84d5-ec4a368003fb"
        ],
        "spl_set_id": [
          "0d65c4a9-938c-4a89-b1f1-d9ada8a8c587"
        ],
        "package_ndc": [
          "55910-562-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0349580462120"
        ]
      }
    }
  ]
}