{"active_ingredient":["Active ingredients (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 • persistent or chronic cough 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 the blood thinning drug warfarin • taking sedatives or tranquilizers"],"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. • if you have ever had an allergic reaction to this product or any of its ingredients • to make a child sleepy"],"dosage_and_administration":["Directions • do not take more than directed (see Liver warning) • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults & children 12 years & over • take 2 tablespoons (TBSP) in dose cup provided every 6 hours • do not take more than 6 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":["take 2 tablespoons (TBSP) in dose cup provided every 6 hours do not take more than 6 tablespoons in 24 hoursdo not use this adult product in children under 12 years of age
adults & children 12 years & over
• •
children under 12 years
•
"],"effective_time":"20181018","id":"8e3d6536-aafa-4e2e-a672-7323e440e76a","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue #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 Compare to the active ingredients in Tylenol® Cold & Cough Nighttime Pain Relief COLD & COUGH NIGHTTIME PAIN RELIEVER, COUGH SUPPRESSANT, ANTIHISTAMINE Instant cooling liquid sensation CONTAINS 3 MEDICINES Sore Throat, Body Aches/Headache – Acetaminophen Coughing – Dextromethorphan HBr Runny Nose – Doxylamine succinate Cold & Cough Nighttime Label Image 1 Cold & Cough Nighttime Label Image 2 Cold & Cough Nighttime Label Image 3"],"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":"cb15c697-6a00-48a0-ac7c-c488383cfd1e","spl_product_data_elements":["cold and cough nighttime 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 25 mg and sodium 8 mg • store between 20-25°C (68-77°F). Do not refrigerate."],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoons (3,000 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • 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. • if you have ever had an allergic reaction to this product or any of its ingredients • 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 • persistent or chronic cough 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 the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • excitability may occur, especially in children • may cause marked drowsiness • 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 • may cause marked drowsiness • alcohol, sedatives and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery"]}