{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Mucus Congestion and Cough Relief Childrens Dextromethorphan HBr, Guaifensin, Phenylephrine HCI DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SUCRALOSE XANTHAN GUM EDETATE DISODIUM PROPYL GALLATE SODIUM BENZOATE SODIUM CITRATE SORBITOL"
      ],
      "active_ingredient": [
        "Active ingredients (in each 5 mL) Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCI 2.5 mg"
      ],
      "purpose": [
        "Purposes Cough suppressant Expectorant Nasal decongestant"
      ],
      "indications_and_usage": [
        "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose"
      ],
      "warnings": [
        "Warnings Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma When using this product, do not use more than directed. Stop use and ask a doctor if your child gets nervous, dizzy, or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. 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 in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."
      ],
      "ask_doctor": [
        "Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma"
      ],
      "when_using": [
        "When using this product, do not use more than directed."
      ],
      "stop_use": [
        "Stop use and ask a doctor if your child gets nervous, dizzy, or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition."
      ],
      "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 do not take more than 6 doses in any 24-hour period use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. keep dosing cup with product dose as follows or as directed by a doctor mL = milliliter age dose children 6 years to under 12 years 10 mL every 4 hours children 4 years to under 6 years 5 mL every 4 hours children under 4 years do not use"
      ],
      "dosage_and_administration_table": [
        "<table><col/><col/><tbody><tr><td align=\"center\" styleCode=\" Botrule Toprule\">age</td><td align=\"center\" styleCode=\" Botrule Toprule\"> dose </td></tr><tr><td styleCode=\" Botrule\"> children 6 years to under 12 years </td><td styleCode=\" Botrule\"> 10 mL every 4 hours </td></tr><tr><td styleCode=\" Botrule\"> children 4 years to under 6 years</td><td styleCode=\" Botrule\"> 5 mL every 4 hours</td></tr><tr><td styleCode=\" Botrule\"> children under 4 years</td><td styleCode=\" Botrule\"> do not use</td></tr></tbody></table>"
      ],
      "spl_unclassified_section": [
        "Other information each 5 mL contains : sodium 5 mg store between 20-25ºC (68-77ºF). Do not refrigerate."
      ],
      "inactive_ingredient": [
        "Inactive ingredients anhydrous citric acid, disodium EDTA, 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 ingredients in Children's Mucinex® Congestion & Cough†† Children's Mucus Congestion & Cough Relief DEXTROMETHORPHAN HBr 5 mg / COUGH SUPPRESSANT GUAIFENESIN 100 mg / EXPECTORANT PHENYLEPHRINE HCI 2.5 mg / NASAL DECONGESTANT Alcohol Free Relief from chest congestion, cough & stuffy nose Breaks up mucus AGES 4 - 11 YEARS Berry flavor DOSAGE CUP PROVIDED FL OZ (mL) ††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Congestion & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com",
        "Package Label WALGREENS Children's Mucus Congestion & Cough Berry Flavor Dextromethorphan HBr 5 mg, Guaifenesin 100 mg, Phenylephrine HCl 2.5 mg"
      ],
      "set_id": "19cd2409-d56b-4319-833c-eacc7dc498c1",
      "id": "8acde3c8-9a96-4e3e-8908-8bf0513c9e72",
      "effective_time": "20240508",
      "version": "5",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Mucus Congestion and Cough Relief Childrens"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI"
        ],
        "manufacturer_name": [
          "Walgreens"
        ],
        "product_ndc": [
          "0363-0512"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1043543"
        ],
        "spl_id": [
          "8acde3c8-9a96-4e3e-8908-8bf0513c9e72"
        ],
        "spl_set_id": [
          "19cd2409-d56b-4319-833c-eacc7dc498c1"
        ],
        "package_ndc": [
          "0363-0512-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0311917212845"
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "9D2RTI9KYH",
          "495W7451VQ",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}