{"active_ingredient":["Active ingredients (in each 5 mL) Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg"],"ask_doctor":["Ask a doctor before use if the child has • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • chronic cough that lasts or as occurs with asthma • a breathing problem such as chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers"],"do_not_use":["Do not use • in a child under 4 years of age • 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. • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy"],"dosage_and_administration":["Directions • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor. • use enclosed dosing cup only. Keep for use with this product only. 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=\"25%\"/> <col width=\"26%\"/> <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</paragraph> <paragraph>4 years of age</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"> <paragraph>do not use</paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children 4 to under</paragraph> <paragraph>6 years of age</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"> <paragraph>do not use unless</paragraph> <paragraph>directed by a doctor</paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>children 6 to under</paragraph> <paragraph>12 years of age</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"> <paragraph>10 mL</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20191217","id":"8ae433c4-bb1f-4a4b-b428-b95fa37ee6e6","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate"],"indications_and_usage":["Uses • temporarily relieves: • sneezing • itchy nose or throat • runny nose • 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"],"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)."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel ACTIVE INGREDIENTS IN CHILLDREN’S TRIAMINIC® NIGHT TIME COLD & COUGH FOR AGES 6 – 12 YEARS children’s nighttime cold & cough TRIACTING SYRUP ANTIHISTAMINE/COUGH SUPPRESSANT (DIPHENHYDRAMINE HCl) NASAL DECONGESTANT (PHENYLEPHRINE HCl) GRAPE FLAVOR RELIEVES: COUGH - RUNNY, STUFFY NOSE ITCHY THROAT 4 FL OZ (118 mL) SmartSense Children's Nighttime Cold & Cough image"],"purpose":["Purposes Antihistamine/cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"fa196684-98da-47af-bd78-99d1fef06960","spl_product_data_elements":["Smart Sense Childrens Nighttime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE"],"stop_use":["Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not improve within 7 days or occur with fever • cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition."],"storage_and_handling":["Other information • each 5 mL contains: sodium 3 mg • store at 20-25 ° C (68-77 ° F)"],"version":"3","warnings":["Warnings Do not use • in a child under 4 years of age • 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. • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if the child has • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • chronic cough that lasts or as occurs with asthma • a breathing problem such as chronic bronchitis Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product • do not exceed recommended dosage • may cause marked drowsiness • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not improve within 7 days or occur with fever • cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign 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)."],"when_using":["When using this product • do not exceed recommended dosage • may cause marked drowsiness • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children"]}