{"active_ingredient":["Active ingredients (in each 5 mL = 1 teaspoon) Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg"],"ask_doctor":["Ask a doctor before use if your child has • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • persistent or chronic cough such as occurs with asthma • cough that occurs with too much phlegm (mucus) • a breathing problem such as chronic bronchitis • glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if your child is • 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. • to make a child sleepy • in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. • if your child has ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed (see Liver warning) • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • if needed, repeat dose every 4-6 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 36 lbs under 4 years do not use 36-47 lbs 4-5 years do not use unless directed by a doctor 48-95 lbs 6-11 years 2 tsp or 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device."],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"27%\"/> <col width=\"25%\"/> <col width=\"41%\"/> <tbody> <tr> <td align=\"center\" styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>Weight (lb) </paragraph> </td> <td align=\"center\" styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>Age (yr)</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>Dose (tsp or mL)</paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>under 36 lbs</paragraph> </td> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>under 4 years</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>do not use</paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>36-47 lbs</paragraph> </td> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>4-5 years</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>do not use unless directed by a doctor</paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>48-95 lbs</paragraph> </td> <td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>6-11 years</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>2 tsp or 10 mL</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20171115","id":"d767169f-e00c-4e05-8036-6bd7d3a7d90c","inactive_ingredient":["Inactive ingredients anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum"],"indications_and_usage":["Uses • temporarily relieves the following cold/flu symptoms: • minor aches and pains • headache • sore throat • cough • stuffy nose • sneezing and runny nose • temporarily reduces fever"],"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 even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredients of Children’s Tylenol® Plus Multi-Symptom Cold For Ages 6 to 11 MULTI-SYMPTOM COLD Children’s Multi-Symptom Cold Relief Fever Reducer, Pain Reliever, Cough Suppressant, Nasal Decongestant, Antihistamine Contains 4 Ingredients: Fever and Sore Throat Acetaminophen Cough Dextromethorphan HBr Stuffy Nose Phenylephrine HCl Sneezing and Runny Nose Chlorpheniramine Maleate Grape Flavor Oral Suspension 4 FL OZ (118 mL) Smart Sense Children's Multi-Symptom Cold Relief Image 1 Smart Sense Children's Multi-Symptom Cold Relief Image 2"],"purpose":["Purpose Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"93be8e08-d931-415c-9972-353d6aad264f","spl_product_data_elements":["Smart Sense Childrens Multi Symptom Cold Relief Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CARRAGEENAN D&C RED NO. 33 EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POLYSORBATE 80 WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM ANHYDROUS CITRIC ACID CALCIUM SULFATE SODIUM PHOSPHATE, TRIBASIC opaque"],"stop_use":["Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion or cough gets worse or lasts more than 5 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 teaspoon contains: sodium 3 mg • store between 20-25°C (68-77°F) • do not use if printed neckband is broken or missing"],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen 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. • to make a child sleepy • in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. • if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • persistent or chronic cough such as occurs with asthma • cough that occurs with too much phlegm (mucus) • a breathing problem such as chronic bronchitis • glaucoma Ask a doctor or pharmacist before use if your child is • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • do not exceed recommended dosage • excitability may occur, especially in children • may cause marked drowsiness • sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion or cough gets worse or lasts more than 5 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. 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 even if you do not notice any signs or symptoms."],"when_using":["When using this product • do not exceed recommended dosage • excitability may occur, especially in children • may cause marked drowsiness • sedatives and tranquilizers may increase drowsiness"]}