{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CALCIUM SILICATE MANNITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN MAGNESIUM STEARATE POTASSIUM BICARBONATE SODIUM BICARBONATE SUCRALOSE POVIDONE, UNSPECIFIED MALTODEXTRIN ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID DIMETHICONE Berry SINUS"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients (in each tablet) Purposes Acetaminophen 325 mg…………….………...Pain reliever/fever reducer Chlorpheniramine maleate 2 mg……………………..……..Antihistamine Dextromethorphan hydrobromide 10 mg……………Cough suppressant Phenylephrine hydrochloride 5 mg………………….Nasal decongestant"
      ],
      "purpose": [
        ""
      ],
      "indications_and_usage": [
        "Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat runny nose sneezing nasal congestion sinus congestion and pressure temporarily reduces fever"
      ],
      "warnings": [
        "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 10 tablets in 24 hours, which is the maximum daily amount for this product · 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. Do not use to sedate children. 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 drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers Ask a doctor before use if you have ● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● glaucoma ● cough that is accompanied by excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a breathing problem such as emphysema or chronic bronchitis ● difficulty in urination due to enlargement of the prostate gland ● a sodium restricted diet When using this product do not exceed recommended dosage may cause marked drowsiness alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."
      ],
      "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 drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have ● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● glaucoma ● cough that is accompanied by excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a breathing problem such as emphysema or chronic bronchitis ● difficulty in urination due to enlargement of the prostate gland ● a sodium restricted diet"
      ],
      "when_using": [
        "When using this product do not exceed recommended dosage may cause marked drowsiness alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"
      ],
      "stop_use": [
        "Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, 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 right away. 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 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use"
      ],
      "other_safety_information": [
        "Other information each tablet contains: potassium 80 mg; sodium 356 mg store between 20 o C to 25 o C (68 o F to 77 o F). Avoid excessive heat above 40 o C (104 o ​F)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose"
      ],
      "questions": [
        "Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)"
      ],
      "package_label_principal_display_panel": [
        "PDP"
      ],
      "set_id": "507284c3-cad9-d65c-e063-6394a90a58a8",
      "id": "507284c3-cad7-d65c-e063-6394a90a58a8",
      "effective_time": "20260427",
      "version": "1",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve"
        ],
        "generic_name": [
          "CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Bayer HealthCare LLC."
        ],
        "product_ndc": [
          "0280-8274"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "CHLORPHENIRAMINE MALEATE",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "spl_id": [
          "507284c3-cad7-d65c-e063-6394a90a58a8"
        ],
        "spl_set_id": [
          "507284c3-cad9-d65c-e063-6394a90a58a8"
        ],
        "package_ndc": [
          "0280-8274-24"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0016500598916"
        ],
        "unii": [
          "362O9ITL9D",
          "V1Q0O9OJ9Z",
          "9D2RTI9KYH",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}