{"active_ingredient":["Active ingredient (in each caplet) 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 • 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)"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are 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."],"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 hours • do not take more than 12 caplets in 24 hours • swallow whole – do not crush, chew or dissolve 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=\"31%\"/> <col width=\"69%\"/> <tbody> <tr> <td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 12 years and over</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <list listType=\"ordered\"> <item> <caption>&#x2022;</caption>take 2 caplets every 4 hours</item> <item> <caption>&#x2022;</caption>do not take more than 12 caplets in 24 hours</item> <item> <caption>&#x2022;</caption>swallow whole &#x2013; do not crush, chew or dissolve</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":"20171113","id":"0ef3e5bb-391f-4a31-abbf-3bb2e9fdc842","inactive_ingredient":["Inactive ingredients acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, 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 • helps clear nasal passages"],"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 Compare to Tylenol® Cold Head Congestion Daytime active ingredients Cold Head Congestion Daytime Non-Drowsy Contains 3 Medicines: Pain Reliever - Acetaminophen Nasal Decongestant - Phenylephrine HCl Cough Suppressant – Dextromethorphan HBr Headache Pain/Sore Throat Nasal Congestion Coughing Instant Cooling Sensation Cool Ice® 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 Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"e36bae47-3e36-4689-beed-07e46d7c9d6e","spl_product_data_elements":["Leader Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM CARNAUBA WAX MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL POVIDONES SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE L402"],"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."],"storage_and_handling":["Other information • 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 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. 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) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed 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"]}