{
  "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": "2026-10-02",
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  "results": [
    {
      "spl_product_data_elements": [
        "Nighttime Cold and Flu Maximum Strength Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 GLYCERIN PROPYLENE GLYCOL WATER SORBITOL ANHYDROUS CITRIC ACID FD&C RED NO. 40 PROPYL GALLATE SODIUM BENZOATE SODIUM CITRATE SUCRALOSE XANTHAN GUM EDETATE CALCIUM DISODIUM"
      ],
      "active_ingredient": [
        "Active ingredients (in each 20 mL) Acetaminophen 650 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 10 mg"
      ],
      "purpose": [
        "Purpose Pain reliever/fever reducer Antihistamine / cough suppressant Nasal decongestant"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves these common cold and flu symptoms cough nasal congestion minor ache and pains sore throat headache runny nose sneezing 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 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 with any other 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 Ask a doctor before use if you have 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) Ask a doctor or pharmacist before use if you are you are taking the blood thinning drug warfarin you are taking sedatives or tranquilizers When using this product do not use more than directed excitability may occur, especially in children avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery 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, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) can 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."
      ],
      "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. 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"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have 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)"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are you are taking the blood thinning drug warfarin you are taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product do not use more than directed excitability may occur, especially in children avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
      ],
      "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 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) can 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."
      ],
      "dosage_and_administration": [
        "Directions do not take more than directed (see Overdose warning) 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 keep dosing cup with product mL = milliliter 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"
      ],
      "storage_and_handling": [
        "Other information each 20 mL contains: sodium 12 mg store between 20-25ºC (68-77F). Do not refrigerate"
      ],
      "inactive_ingredient": [
        "Inactive ingredients 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? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Compare to the active ingredient in Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu†† NIGHTTIME Cold & Flu ACETAMINOPHEN / PAIN RELIEVER & FEVER REDUCER DIPHENHYDRAMINE HCI / ANTIHISTAMINE / COUGH SUPPRESSANT PHENYLEPHRINE HCI / NASAL DECONGESTANT MAXIMUM STRENGTH Relieves aches, fever & sore throat, nasal congestion, runny nose & sneezing Controls cough 12 years & older FL OZ (mL) ††This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademarks Mucinex® and Fast-Max®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY : WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com",
        "Product Label WALGREENS Nighttime Cold & Flu Acetaminophen 650 mg, Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg"
      ],
      "set_id": "37896933-3ed3-457f-8a32-ee0d784a19e8",
      "id": "e52e087d-ec2a-49b7-8d47-955d8c0daa93",
      "effective_time": "20260827",
      "version": "8",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Nighttime Cold and Flu Maximum Strength"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI"
        ],
        "manufacturer_name": [
          "Walgreens"
        ],
        "product_ndc": [
          "0363-0460"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1375932"
        ],
        "spl_id": [
          "e52e087d-ec2a-49b7-8d47-955d8c0daa93"
        ],
        "spl_set_id": [
          "37896933-3ed3-457f-8a32-ee0d784a19e8"
        ],
        "package_ndc": [
          "0363-0460-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0311917177762"
        ],
        "unii": [
          "362O9ITL9D",
          "TC2D6JAD40",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}