{
  "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": [
        "Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool Oxymetazoline hydrochloride, Acetaminophen and Guaifenesin Mucinex Sinus Max Clear and Cool Acetaminophen and Guaifenesin GELATIN GLYCERIN HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL FD&C BLUE NO. 1 LECITHIN, SUNFLOWER SORBITOL SOLUTION LIGHT MINERAL OIL TITANIUM DIOXIDE GUAIFENESIN GUAIFENESIN POVIDONE ACETAMINOPHEN ACETAMINOPHEN WATER AR09 MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL Oxymetazoline hydrochloride OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE BENZALKONIUM CHLORIDE BENZODODECINIUM CHLORIDE CAMPHOR (NATURAL)"
      ],
      "active_ingredient": [
        "Active ingredient Purpose Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant Active ingredients (in each capsule) Purposes Acetaminophen 325 mg.........................................Pain reliever/fever reducer Guaifenesin 200 mg...................................................................Expectorant"
      ],
      "indications_and_usage": [
        "Uses ■ temporarily relieves nasal congestion due to: ■ a cold ■ hay fever or other upper respiratory allergies ■ promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure ■ helps clear nasal passages; shrinks swollen membranes Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily reduces fever"
      ],
      "warnings": [
        "Warnings Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland When using this product ■ do not exceed recommended dosage ■ do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. ■ this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge ■ the use of this container by more than one person may spread infection Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 12 capsules in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily 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."
      ],
      "dosage_and_administration": [
        "Directions ■ adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. ■ children under 6 years of age: consult a doctor. Shake well before use. To open, hold by the white grips then squeeze, push down firmly and turn cap counterclockwise. Before using for the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle between first and second fingers.Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply.Wipe nozzle clean after use. To close, turn cap clockwise. DO NOT DISCARD CAP. Directions ■ do not take more than directed (see Overdose warning) ■ do not take more than 12 capsules in any 24-hour period ■ adults and children 12 years of age and over: take 2 capsules every 4 hours ■ children under 12 years of age: do not use"
      ],
      "other_safety_information": [
        "Other information ■ store at 20-25°C (68-77°F) ■ avoid excessive heat"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzalkonium chloride, benzododecinium chloride, camphor, cetalkonium chloride, colloidal silicon dioxide, edetate disodium, eucalyptol, glycine, linoleic acid, linolenic acid, menthol, myristalkonium chloride, myristic acid, oleic acid, palmitic acid, palmitoleic acid, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium carbonate, sodium chloride, sodium hydroxide, stearic acid Inactive ingredients FD&C blue no.1, gelatin, glycerin, hypromellose, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of Children"
      ],
      "purpose": [
        "Purpose Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant Acetaminophen 325 mg.........................................Pain reliever/fever reducer Guaifenesin 200 mg...................................................................Expectorant"
      ],
      "package_label_principal_display_panel": [
        "full carton label back label"
      ],
      "set_id": "33f0d9bb-c67d-92ba-e063-6294a90a9943",
      "id": "51b4bab5-5696-f605-e063-6394a90a190f",
      "effective_time": "20260513",
      "version": "2",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool"
        ],
        "generic_name": [
          "OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN"
        ],
        "manufacturer_name": [
          "Reckitt Benckiser LLC"
        ],
        "product_ndc": [
          "72854-216"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "rxcui": [
          "707195",
          "1000990"
        ],
        "spl_id": [
          "51b4bab5-5696-f605-e063-6394a90a190f"
        ],
        "spl_set_id": [
          "33f0d9bb-c67d-92ba-e063-6294a90a9943"
        ],
        "package_ndc": [
          "72854-216-02",
          "72854-211-08",
          "63824-129-17"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}