{
    "spl_product_data_elements": [
        "Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride SORBITAN GUAIFENESIN GUAIFENESIN WATER GELATIN MEDIUM-CHAIN TRIGLYCERIDES POVIDONE SORBITOL SHELLAC POTASSIUM ALUMINUM DISILICATE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C RED NO. 40 LECITHIN, SOYBEAN PROPYLENE GLYCOL SODIUM HYDROXIDE TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED ASP;S"
    ],
    "spl_unclassified_section": [
        "Drug Facts"
    ],
    "active_ingredient": [
        "Active ingredients Active ingredients (in each capsule) Purposes Acetaminophen 325 mg\u2026\u2026\u2026\u2026\u2026.\u2026\u2026\u2026\u2026.Pain reliever/fever reducer Dextromethorphan hydrobromide 10 mg\u2026\u2026\u2026\u2026\u2026..Cough suppressant Guaifenesin 200 mg\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..Expectorant Phenylephrine hydrochloride 5 mg\u2026\u2026\u2026\u2026\u2026\u2026\u2026...Nasal decongestant"
    ],
    "purpose": [
        "Purpose"
    ],
    "indications_and_usage": [
        "Uses Uses \u00b7 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive \u00b7 temporarily relieves these symptoms due to a cold or flu: \u00b7 nasal congestion \u00b7 sinus congestion and pressure \u00b7 minor aches and pains \u00b7 headache \u00b7 cough \u00b7 sore throat \u00b7 temporarily reduces fever"
    ],
    "warnings": [
        "Warnings Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take \u00b7 more than 10 capsules in 24 hours, which is the maximum daily amount for this product \u00b7 with other drugs containing acetaminophen \u00b7 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: \u00b7 skin reddening \u00b7 blisters \u00b7 rash \u00b7 hives \u00b7 facial swelling \u00b7 asthma (wheezing) \u00b7 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 Do not use \u25cf with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. \u25cf 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. \u25cf if you have ever had an allergic reaction to this product or any of its ingredients \u25cf in children under 12 years of age Ask a doctor before use if you have Ask a doctor before use if you have \u25cf liver disease \u25cf heart disease \u25cf high blood pressure \u25cf thyroid disease \u25cf diabetes \u25cf cough is accompanied by excessive phlegm (mucus) \u25cf persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema \u25cf difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage When using this product do not exceed recommended dosage Stop use and ask a doctor if Stop use and ask a doctor if \u00b7 pain, cough, or nasal congestion gets worse or lasts more than 7 days \u00b7 fever gets worse or lasts more than 3 days \u00b7 redness or swelling is present \u00b7 new symptoms occur \u00b7 cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. \u00b7 nervousness, dizziness, or sleeplessness occurs If pregnant 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."
    ],
    "do_not_use": [
        "Do not use Do not use \u25cf with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. \u25cf 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. \u25cf if you have ever had an allergic reaction to this product or any of its ingredients \u25cf in children under 12 years of age"
    ],
    "ask_doctor": [
        "Ask a doctor before use if you have Ask a doctor before use if you have \u25cf liver disease \u25cf heart disease \u25cf high blood pressure \u25cf thyroid disease \u25cf diabetes \u25cf cough is accompanied by excessive phlegm (mucus) \u25cf persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema \u25cf difficulty in urination due to enlargement of the prostate gland"
    ],
    "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin"
    ],
    "when_using": [
        "When using this product do not exceed recommended dosage When using this product do not exceed recommended dosage"
    ],
    "stop_use": [
        "Stop use and ask a doctor if Stop use and ask a doctor if \u00b7 pain, cough, or nasal congestion gets worse or lasts more than 7 days \u00b7 fever gets worse or lasts more than 3 days \u00b7 redness or swelling is present \u00b7 new symptoms occur \u00b7 cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. \u00b7 nervousness, dizziness, or sleeplessness occurs"
    ],
    "pregnancy_or_breast_feeding": [
        "If pregnant 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 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 Directions \u00b7 do not take more than the recommended dose \u00b7 adults and children 12 years and over: take 2 capsules every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. \u00b7 children under 12 years: do not use"
    ],
    "other_safety_information": [
        "Other information Other information \u00b7 store at 15\u00b0 - 25\u00b0C (59\u00b0 - 77\u00b0F)"
    ],
    "inactive_ingredient": [
        "Inactive ingredients Inactive ingredients FD&C red #40, gelatin, glycerin, lecithin, medium chain triglycerides, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol-sorbitan solution, titanium dioxide"
    ],
    "questions": [
        "Questions or commens Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)"
    ],
    "package_label_principal_display_panel": [
        "Package label carton 24 PDP"
    ],
    "set_id": "51535c7d-260e-71e5-e063-6294a90aee1f",
    "id": "51a46482-87c8-24da-e063-6294a90a1552",
    "effective_time": "20260512",
    "version": "2",
    "openfda": {
        "application_number": [
            "M012"
        ],
        "brand_name": [
            "Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax"
        ],
        "generic_name": [
            "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
            "Bayer HealthCare LLC."
        ],
        "product_ndc": [
            "0280-8278"
        ],
        "product_type": [
            "HUMAN OTC DRUG"
        ],
        "route": [
            "ORAL"
        ],
        "substance_name": [
            "ACETAMINOPHEN",
            "DEXTROMETHORPHAN HYDROBROMIDE",
            "GUAIFENESIN",
            "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "spl_id": [
            "51a46482-87c8-24da-e063-6294a90a1552"
        ],
        "spl_set_id": [
            "51535c7d-260e-71e5-e063-6294a90aee1f"
        ],
        "package_ndc": [
            "0280-8278-24"
        ],
        "is_original_packager": [
            true
        ],
        "upc": [
            "0016500584209"
        ],
        "nui": [
            "N0000193956",
            "N0000008867",
            "N0000009560"
        ],
        "pharm_class_epc": [
            "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
            "Decreased Respiratory Secretion Viscosity [PE]",
            "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
            "362O9ITL9D",
            "9D2RTI9KYH",
            "495W7451VQ",
            "04JA59TNSJ"
        ]
    }
}