{"active_ingredient":["Active ingredient Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • diabetes • cough that occurs with too much phlegm (mucus) • thyroid disease • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema • trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are","Ask Doctor or Pharmacist before use if you are • taking the blood thinning drug warfarin"],"do_not_use":["Do Not Use • in a child under 4 years of age • if you are allergic to acetaminophen • 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."],"dosage_and_administration":["Directions • do not use more than directed • take every 4 hours, while symptoms persist • do not take more than12 caplets in 24 hours Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over 2 caplets"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"52%\"/> <col width=\"48%\"/> <tbody> <tr> <td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>Age</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"> <paragraph>Dose</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">children under 4 years of age</content> </paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">do not use</content> </paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children 4 to under 12 years of age</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>do not use unless directed by a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>adults and children 12 years of age and over</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>2 caplets</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20190725","id":"ddf14cdc-89b3-4471-96e4-c00eea0cd100","inactive_ingredient":["Inactive ingredients benzoic acid, carnauba wax, D&C yellow #10 lake, FD&C red #40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieve • headache • sore throat pain • minor aches and pains • nasal and sinus congestion • cough due to minor throat and bronchial irritation as may occur with a cold • temporarily reduces fever"],"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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Principal Display Carton Image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health care professional before use."],"purpose":["Purpose Pain reliever / fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or comments? call 1-800-452-0051 Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622"],"set_id":"717009a9-877f-47ac-971f-f44c87ef5e5a","spl_product_data_elements":["COMTREX Maximum Strength Cold and Cough Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID CARNAUBA WAX D&C YELLOW NO. 10 FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 STARCH, CORN STEARIC ACID TITANIUM DIOXIDE Orange Capsule shaped tablet Cx;A"],"stop_use":["Stop Use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur • redness or swelling is present • symptoms do not get better or worsen • fever gets worse or lasts more than 3 days • pain, cough or nasal congestion gets worse or lasts more than 7 days • cough comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information • store at controlled room temperature 20-25°C (68-77°F)"],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 12 caplets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product 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."],"when_using":["When using this product • do not exceed recommended dosage"]}