{"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=\"20%\"/> <col width=\"23%\"/> <col width=\"37%\"/> <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":"20171105","id":"330c48bd-8d94-4c8f-97e1-9ff110af7ca5","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 • stuffy nose • cough • 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 active ingredients in Children’s Tylenol® Plus Multi-Symptom Cold children's multi-symptom cold pain relief plus fever reducer/pain reliever, cough suppressant, nasal decongestant, antihistamine acetaminophen - fever/sore throat dextromethorphan HBr - cough phenylephrine HCl - stuffy nose chlorpheniramine maleate - sneezing/runny nose oral suspension GRAPE FLAVOR AGE 6-11 YEARS 4 FL OZ (118 mL) Compare to active ingredients in Children’s Tylenol® Plus Multi-Symptom Cold"],"purpose":["Purpose Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant"],"questions":["Questions? Call 1-800-910-6874"],"set_id":"97844d85-761a-4341-a3ef-bd33c42644d4","spl_product_data_elements":["up and up childrens multi symptom cold pain relief plus Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID CALCIUM SULFATE 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 SODIUM PHOSPHATE, TRIBASIC XANTHAN GUM 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":"4","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"]}