{"active_ingredient":["Active ingredient (in each 15 mL = 1 tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma 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 sedatives or tranquilizers • taking the blood thinning drug warfarin"],"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. • to make a child sleepy"],"dosage_and_administration":["Directions • do not take more than directed (see Liver warning) adults and children 12 years and over • take 2 tablespoons (TBSP) in dose cup provided every 6 hours as needed • do not take more than 8 tablespoons in 24 hours children under 12 years • do not use this adult product in children under 12 years of age"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"29%\"/> <col width=\"71%\"/> <tbody> <tr> <td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 12 years </paragraph> <paragraph>and over</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <list listType=\"ordered\"> <item> <caption>&#x2022;</caption>take 2 tablespoons (TBSP) in dose cup provided every 6 hours as needed</item> <item> <caption>&#x2022;</caption>do not take more than 8 tablespoons in 24 hours</item> </list> </td> </tr> <tr> <td styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>children under 12 years</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <list listType=\"ordered\"> <item> <caption>&#x2022;</caption>do not use this adult product in children under 12 years of age</item> </list> </td> </tr> </tbody> </table>"],"effective_time":"20181019","id":"25e66def-ba34-43c9-8316-ccaffd04d3b2","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose"],"indications_and_usage":["Uses • temporarily relieves the following cold/flu symptoms: • minor aches and pains • headache • sore throat • runny nose and sneezing • cough"],"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. (1-800-222-1222) Quick 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 Panel Pain Relief See New Warnings Information Cough & Sore Throat Sore Throat Headache Runny Nose Body Aches Coughing Cool Ice® Instant Cooling Sensation NightTime Pain Reliever Cough Suppressant Antihistamine Acetaminophen Dextromethorphan HBr Doxylamine Succinate Compare to active ingredients of Tylenol® Cough & Sore Throat Cough & Sore Throat Label Front Cough & Sore Throat Label Front Cough & Sore Throat Label Back Cough & Sore Throat Label Front Cough & Sore Throat Label Back"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever Cough suppressant Antihistamine"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"04c0fed5-bce6-4f02-9955-95f7071676e2","spl_product_data_elements":["good sense cough and sore throat night time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM FD&C BLUE NO. 1 POLYETHYLENE GLYCOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCROSE clear"],"stop_use":["Stop use and ask a doctor if • pain or cough 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."],"storage_and_handling":["Other information • each tablespoon contains: potassium 20 mg and sodium 8 mg • store at 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 4 doses 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. 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. • to make a child sleepy Ask a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • pain or cough 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. 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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery"]}