{"active_ingredient":["Active ingredients (in each 5 mL) 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 • glaucoma • a breathing problem such as chronic bronchitis • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with asthma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if your child is taking • sedatives or tranquilizers • the blood thinning drug warfarin"],"do_not_use":["Do not use • in a child under 4 years of age • if your child has ever had an allergic reaction to this product or any of its ingredients • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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. • to make a child sleepy"],"dosage_and_administration":["Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed (see Overdose warning) • shake well before using • remove the child protective cap and squeeze your child’s dose into the dosing cup • may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor. • use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device. Age Dose children under 4 years of age do not use children 4 to under 6 years of age do not use unless directed by a doctor children 6 to under 12 years of age 10 mL"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"30%\"/><col width=\"47%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Age</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Dose</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children under 4</paragraph><paragraph> years of age</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 4 to under 6</paragraph><paragraph> years of age</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>do not use unless directed by a doctor</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>children 6 to under 12 years of age</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>10 mL</paragraph></td></tr></tbody></table>"],"effective_time":"20201030","id":"656a6dcd-f529-44e2-9d91-ba645ab03dfe","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 • minor aches and pains • headache • minor sore throat pain • runny nose • itchy nose or throat • sneezing • itchy, watery eyes due to hay fever • nasal and sinus congestion • cough due to minor throat and bronchial irritation as may occur with a cold • temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel Suspension Liquid Children’s Pain Relief Plus Multi-Symptom Cold ACETAMINOPHEN Pain reliever; Fever reducer CHLORPHENIRAMINE MALEATE Antihistamine DEXTROMETHORPHAN HBr Cough suppressant PHENYLEPHRINE HCl Nasal decongestant Relieves Pain & fever; Stuffy nose; Cough; Sneezing & runny nose Oral Suspension Grape Flavor Ages 6 to 11 Years Dosage cup included 4 FL OZ (118 mL) 903-17-cold.jpg"],"purpose":["Purposes Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"8f2351f4-2d0b-44c8-b81f-b3949ca9afd6","spl_product_data_elements":["Multi Symptom Cold Relief Childrens Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CARRAGEENAN ANHYDROUS CITRIC ACID 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 SODIUM PHOSPHATE, TRIBASIC CALCIUM SULFATE, UNSPECIFIED FORM 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 5 mL contains: sodium 3 mg • contains no aspirin • store at 20-25 ° C (68-77 ° F). Protect from light. • close cap tightly"],"version":"7","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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. 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 • in a child under 4 years of age • if your child has ever had an allergic reaction to this product or any of its ingredients • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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. • to make a child sleepy Ask a doctor before use if your child has • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • a breathing problem such as chronic bronchitis • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with asthma Ask a doctor or pharmacist before use if your child is taking • sedatives or tranquilizers • the blood thinning drug warfarin When using this product • do not exceed recommended dosage • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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 • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children"]}