{"active_ingredient":["Active Ingredients Acetaminophen 325 mg Dextromethorphan HBr 20 mg Guaifenesin 200 mg Pseudoephedrine HCl 60 mg"],"ask_doctor":["Ask a doctor before use if you have ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating ■ due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough that occurs with too much phlegm (mucus)"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."],"do_not_use":["Do not use this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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"],"dosage_and_administration":["Directions Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours or as directed by a doctor Children under 12 years of age ½ tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor When using this product do not exceed recommended dosage."],"dosage_and_administration_table":["<table><col width=\"199\"/><col width=\"210\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \">Adults and children 12 years of age and over:</td><td styleCode=\"Toprule Lrule Rrule \">1 tablet every 4 hours, not to exceed 6 tablets in 24 hours or as directed by a doctor</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Children under 12 years of age</td><td styleCode=\"Toprule Lrule Rrule \">&#xBD; tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor</td></tr></tbody></table>"],"effective_time":"20241109","id":"2683803e-5e2f-b2bc-e063-6394a90a4feb","inactive_ingredient":["Inactive ingredients magnesium stearate, microcrystalline cellulose, stearic acid"],"indications_and_usage":["Temporarily relieves minor aches and pains fever headache cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes nasal congestion due to the common cold"],"keep_out_of_reach_of_children":["■ KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN 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."],"openfda":{"application_number":["M012"],"brand_name":["Duraflu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Poly Pharmaceuticals, Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["50991-535-01","50991-535-02"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["50991-535"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1673869"],"spl_id":["2683803e-5e2f-b2bc-e063-6394a90a4feb"],"spl_set_id":["55fffc1d-8449-4c28-a391-c6f60dd85622"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE","ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["6V9V2RYJ8N","362O9ITL9D","9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50991-535-01 DURAFLU™ Expectorant/ Nasal Decongestant Antitussive/Pain Reliever 100 Tablets NDC 50991-535-01 DURAFLU™ Expectorant/ Nasal Decongestant Antitussive/Pain Reliever 100 Tablets"],"purpose":["Purpose Pain Reliever Antitussive Expectorant Nasal Decongestant"],"questions":["Questions or comments? 800-882-1041 Manufactured For: Poly Pharmaceuticals, Inc. Huntsville, AL 35763 Rev. 08/15"],"set_id":"55fffc1d-8449-4c28-a391-c6f60dd85622","spl_product_data_elements":["Duraflu ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PE;723"],"spl_unclassified_section":["DurafluTablets Rev. 08/15 Drug Facts","Other information Store at 20°- 25° Celsius (68° – 77° Fahrenheit) as defined in the (USP/NF). Dispense in tight, light-resistant container."],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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"],"version":"8","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: More than 3,000 mg of acetaminophen in 24 hrs; with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not Exceed recommended dosage ■ KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN 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. Do not use this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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 Ask a doctor before use if you have ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating ■ due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough that occurs with too much phlegm (mucus) 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. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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"],"when_using":["When using this product do not exceed recommended dosage."]}