{
  "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": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "MAXIMUM STRENGHT DAY COLD AND FLU FORMULA ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL ACETAMINOPHEN ACETAMINOPHEN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SHELLAC TITANIUM DIOXIDE PROPYLENE GLYCOL SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN WATER 70"
      ],
      "active_ingredient": [
        "Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg"
      ],
      "purpose": [
        "Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant"
      ],
      "indications_and_usage": [
        "Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · nasal and sinus congestion · temporarily reduces fever"
      ],
      "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 or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic 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."
      ],
      "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 right away(1800 222-1222). 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 the recommended dose · adults and children 12 years and over: take 2 sofgels with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide"
      ],
      "package_label_principal_display_panel": [
        "12 CT"
      ],
      "set_id": "aa8ebccf-6813-2dca-e053-2a95a90a032b",
      "id": "2e2d13f2-9446-dd98-e063-6394a90a9abb",
      "effective_time": "20250215",
      "version": "4",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "MAXIMUM STRENGHT DAY COLD AND FLU FORMULA"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL"
        ],
        "manufacturer_name": [
          "FAMILY DOLLAR"
        ],
        "product_ndc": [
          "55319-933"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1086997"
        ],
        "spl_id": [
          "2e2d13f2-9446-dd98-e063-6394a90a9abb"
        ],
        "spl_set_id": [
          "aa8ebccf-6813-2dca-e053-2a95a90a032b"
        ],
        "package_ndc": [
          "55319-933-22"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}