{"active_ingredient":["Active ingredient (in each caplet) Acetaminophen 325 mg Chlorpheniramine maleate 2 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 • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • glaucoma"],"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 caplets every 4-6 hours • swallow whole – do not crush, chew or dissolve • do not take more than 12 caplets 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 caplets every 4-6 hours swallow whole – do not crush, chew or dissolve do not take more than 12 caplets in 24 hoursdo not use this adult product in children under 12 years of age
adults and children 12 years and over
• • •
children under 12 years
•
"],"effective_time":"20171110","id":"9afe7969-7c79-4357-bddd-a7cce99bf971","inactive_ingredient":["Inactive ingredients acesulfame potassium, FD&C blue no. 1 lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves these common cold symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • sinus congestion and pressure • sneezing and runny nose • helps clear nasal passages • relieves cough to help you sleep"],"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 See New Warnings Information Nighttime Cold Head Congestion Pain Reliever, Nasal Decongestant, Cough Suppressant, Antihistamine Contains 4 Medicines: Headache/Sore Throat /Acetaminophen Nasal Congestion/Phenylephrine HCl Coughing/Dextromethorphan HBr Runny Nose/Chlorpheniramine Maleate Instant Cooling Sensation Cool Ice® Compare to Tylenol® Cold Head Congestion Nighttime active ingredients Actual size Cold Head Congestion Carton Cold Head Congestion Carton Cold Head Congestion Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever Antihistamine Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-888-423-0139"],"set_id":"28702a14-bc0b-4624-9f36-fd51a6904c99","spl_product_data_elements":["Topcare Cold Head Congestion Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 Light Blue L393"],"stop_use":["Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, 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."],"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. 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 • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • glaucoma 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 driving a motor vehicle or operating machinery Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, 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 • 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 driving a motor vehicle or operating machinery"]}