{"active_ingredient":["Active ingredients (in each 15 mL tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg"],"ask_doctor":["Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • a sodium-restricted diet"],"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 sleep • if you are allergic to acetaminophen or any of the ingredients in this product."],"dosage_and_administration":["Directions • Take only as recommended - see overdose warning • use dose cup or Tabelspoon (TBSP) every 6 hours as needed • do not exceed 4 doses in 24-hour period Adults and children 12 years of age and over • take 2 tablespoons (tbsp) 30 ml in dose cup provided every 6 hours as needed Children under 12 years • do not use this product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"29%\"/><col width=\"71%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Adults and </paragraph><paragraph>children 12 years of age</paragraph><paragraph>and over</paragraph></td><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>take 2 tablespoons (tbsp) 30 ml in dose cup provided every 6 hours as needed </item></list></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Children under 12 years</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>do not use this product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage</item></list></td></tr></tbody></table>"],"effective_time":"20250529","id":"83e97364-75ce-40ad-8809-cbfcff58b894","inactive_ingredient":["Inactive ingredients carboxy methyl cellulose sodium, citric acid, FD&C Blue #1, flavor, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol and sucrose"],"indications_and_usage":["Uses • sore throat • headache • minor aches and pains • fever • runny nose and sneezing, cough"],"keep_out_of_reach_of_children":["Keep out of reach of children. overdose warning: taking more than recommended dose can cause serious health problems. 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 Panel Cough & Sore Throat Cough & Sore Throat Cough & Sore Throat Front Label Cough & Sore Throat Back Label 1"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever / Fever reducer Cough suppressant Antihistamine"],"questions":["Questions or comments? 1-845-692-5799"],"set_id":"491ad8a0-1d6b-457a-982a-e68b1def7b55","spl_product_data_elements":["Cough and Sore Throat Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 MENTHOL, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM 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 • Store at room temperature 15°- 30°C (59° - 86°F) • Protect from freezing • each tablespoon contains: sodium 21 mg TAMPER EVIDENT: DO NOT USE IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING"],"version":"2","warnings":["Warnings Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Acetaminophen or oter pain releivers/ fever reducers. 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 of this product • 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 sleep • if you are allergic to acetaminophen or any of the ingredients in this product. Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when 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. overdose warning: taking more than recommended dose can cause serious health problems. 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."],"when_using":["When using this product do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when operating machinery"]}