{
  "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",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Daytime Cold and Flu Acetaminophen 325mg/ Dextromethorphan HBr 10mg/ Phenylephrine HCl 5mg ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL SOLUTION PC9"
      ],
      "active_ingredient": [
        "Active ingredient(s) Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg"
      ],
      "purpose": [
        "Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant"
      ],
      "indications_and_usage": [
        "Use(s) temporarily relieves common cold and flu symptoms: ■ nasal congestion ■ cough due to minor throat and bronchial irritation ■ sore throat ■ headache ■ minor aches and pains ■ fever"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 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, lasts for more than 2 days, occurs with or followed by fever, headache, rash, nausea, or vomiting, see 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 drugs. 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 ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ 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 taking the blood thinning drug warfarin. When using this product do not use more than directed Stop use and ask a doctor before use if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days n redness or swelling is present new symptoms occurs cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children 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 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 drugs. 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 ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ 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 taking the blood thinning drug warfarin."
      ],
      "when_using": [
        "When using this product do not use more than directed"
      ],
      "stop_use": [
        "Stop use and ask a doctor before use if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days n redness or swelling is present new symptoms occurs 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 breastfeeding, 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 (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions take only as directed do not exceed 4 doses per 24 hours Adults and children 12 years and over: 2 softgels with water every 4 hours Children 4 to under 12 years: ask a doctor Children under 4 years: do not use"
      ],
      "spl_unclassified_section": [
        "Other information store at room temperature 20-25 °C (68-77°F) do not use if blister unit is torn or open"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white edible ink"
      ],
      "questions": [
        "Questions/Comments Call 1-877-290-4008"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Blister Blister"
      ],
      "set_id": "2f90dfb6-4257-44a8-a685-1873645d1c96",
      "id": "f3fd0eb9-a658-46e6-a4f4-fca72ef40cf2",
      "effective_time": "20260325",
      "version": "4",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Daytime Cold and Flu"
        ],
        "generic_name": [
          "ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG"
        ],
        "manufacturer_name": [
          "Grocery Outlet"
        ],
        "product_ndc": [
          "85828-417"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1086997"
        ],
        "spl_id": [
          "f3fd0eb9-a658-46e6-a4f4-fca72ef40cf2"
        ],
        "spl_set_id": [
          "2f90dfb6-4257-44a8-a685-1873645d1c96"
        ],
        "package_ndc": [
          "85828-417-93"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}