{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "BRONCOCHEM KIDS COLD AND FLU ACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GUAIFENESIN GUAIFENESIN PROPYLENE GLYCOL GLYCERIN SORBITOL SUCRALOSE CITRIC ACID MONOHYDRATE DISODIUM HEDTA POVIDONE K90 SODIUM CITRATE SODIUM CHLORIDE HONEY PROPYL GALLATE FD&C RED NO. 40 ALOE VERA LEAF METHYLPARABEN PROPYLPARABEN RASPBERRY WATER"
      ],
      "warnings": [
        "Warnings Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take: More than 4 doses in 24 hour, wich is the maximum daily amount for this product. With other drugs containing acetaminophen. Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly. allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include: Sking reddening, blisters, rash. If sking reactions occurs, stop use and seek medical attention."
      ],
      "indications_and_usage": [
        "Uses Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat."
      ],
      "active_ingredient": [
        "Active Ingredients Acetaminophen...................325.00mg Guaifenesin........................200.00mg Phenylephrine HCl..................5.00mg"
      ],
      "ask_doctor": [
        "Ask a doctor before use if your kid have Liver disease Persistent or chronic cough, asthma or emphysema If your kid is allergic to acetaminophen or any other componet of this formula"
      ],
      "stop_use": [
        "Stop use and ask a doctor if Symtoms last more than 5 days Fever gets worst or last more than 3 days, or occurs with rash or headache that last, a persistent cough, this could be signs of a serious conditions If your child is taking the bloood thinning drug warfarin"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children Keep out of the reach of children"
      ],
      "overdosage": [
        "Overdose warning In case of accidental overdose. seek professional assistance or contact a poison control center inmediately"
      ],
      "dosage_and_administration": [
        "Directions Take only as directed, for your convenience a dosage spoon is provided. Do not exceed 4 doses in a 24 hour period Children from 6 to 12 years-----10mL or cc every 6 hours Children form 2 to 6 years------5mL or cc every 6 hours Children under 2 years, ask your doctor"
      ],
      "other_safety_information": [
        "Other information store at 66-77*F (20-25*C), do not use if securety cap is altered or broken"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Propylene glycol, glycerin, Sorbitol USP, Sucralose, Citric acid, disodium Hedta, Povidone, Sodium citrate dihydrate, Sodium chloride, Honey, Propyl gallate, FD&C Red #40, Aloe Vera, Methylparaben USP, Propylparaben USP, Bubble Gum flavor, Raspberry flavor, Nat. Masking type #27872, Purified water."
      ],
      "questions": [
        "Quiestions? 1-561-338-5221 or visit us at www.broncochem.com"
      ],
      "purpose": [
        "Purose Acetaminophen...........Analgesic Guaifenesin................Expectorant Phenylephrine.............Decongestant"
      ],
      "package_label_principal_display_panel": [
        "Package principal display panel CAJA BRONCOCHEM KIDS COLD & FLU.jpg",
        "Package Label Principal Display Panel Etiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpg",
        ""
      ],
      "set_id": "523561fb-f6a7-4cde-9be2-bba02e60e208",
      "id": "7ec85034-cc70-4465-bc25-9c700731eb02",
      "effective_time": "20170406",
      "version": "1",
      "openfda": {
        "application_number": [
          "part341"
        ],
        "brand_name": [
          "BRONCOCHEM KIDS COLD AND FLU"
        ],
        "generic_name": [
          "ACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESIN"
        ],
        "manufacturer_name": [
          "LABORATORIO MAGNACHEM INTERNATIONAL SRL"
        ],
        "product_ndc": [
          "65131-054"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1116568"
        ],
        "spl_id": [
          "7ec85034-cc70-4465-bc25-9c700731eb02"
        ],
        "spl_set_id": [
          "523561fb-f6a7-4cde-9be2-bba02e60e208"
        ],
        "package_ndc": [
          "65131-054-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0805418098447"
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "362O9ITL9D",
          "495W7451VQ",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}