{"active_ingredient":["Active ingredient (in each 5 mL, 1 teaspoon) Diphenhydramine HCl, USP 6.25 mg Phenylephrine HCl, USP 2.5 mg"],"ask_doctor":["Ask a doctor before use if the child has • high blood pressure • thyroid disease • glaucoma • diabetes • cough that occurs with too much phlegm (mucus) • a breathing problem such as chronic bronchitis • cough that lasts or is chronic such as occurs with asthma • heart disease"],"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 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 • take every 4 hours; not to exceed 6 doses in 24 hours or as directed by a doctor children 6 to under 12 years of age 2 teaspoons (tsp) children 4 to under 6 years of age do not use unless directed by a doctor children under 4 years of age do not use"],"dosage_and_administration_table":["
children 6 to under 12 years of age 2 teaspoons (tsp)
children 4 to under 6 years of age do not use unless directed by a doctor
children under 4 years of age do not use
"],"effective_time":"20171126","id":"df1a4ea8-8914-46f4-819e-12cbb574e0be","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate"],"indications_and_usage":["Uses • temporarily relieves • itchy, watery eyes due to hay fever • sneezing • nasal and sinus congestion • runny nose • itchy nose or throat • cough due to minor throat and bronchial irritation"],"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."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel compare to Children's Triaminic® Night Time Cold & Cough active ingredients children’s nighttime cold & cough diphenhydramine HCl (antihistamine/cough suppressant), phenylephrine HCl (nasal decongestant) relieves: cough runny, stuffy nose itchy throat for ages 6 to 12 grape flavor ALCOHOL FREE 4 FL OZ (118mL) Children't Nighttime Cold & Cough Carton Image 1 Children't Nighttime Cold & Cough Carton Image 2"],"purpose":["Purpose Antihistamine/cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-877-932-7948"],"set_id":"d05d83a4-76f7-4786-8cff-c1314cede623","spl_product_data_elements":["equaline night time cold and cough childrens Diphenhydramine HCl, Phenylephrine HCl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE MALTITOL"],"stop_use":["Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occurs • symptoms do not get better within 7 days or occur with fever • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. A persistent cough may be a sign of a serious condition."],"storage_and_handling":["Other information • each teaspoon contains: sodium 3 mg • store at 20º-25ºC (68º-77ºF)"],"version":"3","warnings":["Warnings Do not use • 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 • high blood pressure • thyroid disease • glaucoma • diabetes • cough that occurs with too much phlegm (mucus) • a breathing problem such as chronic bronchitis • cough that lasts or is chronic such as occurs with asthma • heart disease 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 occurs • symptoms do not get better within 7 days or occur with fever • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. 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."],"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"]}