{"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 a breathing problem such as chronic bronchitis chronic cough that lasts, or as occurs with asthma cough that occurs with too much phlegm (mucus)"],"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 the 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 for the purpose of making your child sleepy"],"dosage_and_administration":["Directions Do not give more than 6 doses in 24 hours unless directed by a doctor. measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter shake well before using age dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years do not use unless directed by a doctor children under 4 years of age do not use"],"dosage_and_administration_table":["
age dose
children 6 to under 12 years10 mL every 4 hours
children 4 to under 6 yearsdo not use unless directed by a doctor
children under 4 years of age do not use
"],"effective_time":"20231013","id":"f4d797cd-2bcd-41e6-b683-93d70e31da64","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate"],"indications_and_usage":["Uses temporarily relieves: sneezing runny nose itchy nose or throat 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 (1-800-222-1222) right away."],"openfda":{"application_number":["M012"],"brand_name":["Childrens Triacting Nighttime Cold and Cough ReadyInCase"],"generic_name":["DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["P & L Development, LLC"],"package_ndc":["49580-0379-4"],"product_ndc":["49580-0379"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1236048"],"spl_id":["f4d797cd-2bcd-41e6-b683-93d70e31da64"],"spl_set_id":["61980e57-5b94-4ae2-8e08-848749e4abcd"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["04JA59TNSJ","TC2D6JAD40"],"upc":["0349580379404"]},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredients in Children's Triaminic® Nighttime Cold & Cough children's triacting nighttime Cold & Cough Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg antihistamine/ cough suppressant nasal decongestant relieves: cough runny, stuffy nose itchy throat for ages 6 to 11 Grape Flavor FL OZ (mL) *This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING. Manufactured by: PL Developments 11865 S. Alameda St Lynwood, CA 90262","Package Label READYinCASE Children's Triacting Night Time Cold and Cough Diphenhydramine HCl 6.25 mg, Phenylephrine HCl 2.5 mg"],"purpose":["Purposes Antihistamine/Cough suppressant Nasal decongestant"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"61980e57-5b94-4ae2-8e08-848749e4abcd","spl_product_data_elements":["Childrens Triacting Nighttime Cold and Cough ReadyInCase Diphenhydramine HCl, Phenylephrine HCl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACESULFAME POTASSIUM SODIUM BENZOATE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 PROPYLENE GLYCOL WATER TRISODIUM CITRATE DIHYDRATE FD&C BLUE NO. 1 MALTITOL"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition."],"storage_and_handling":["Other information each 5 mL contains : sodium 3 mg store between 20-25°C (68-77°F). Do not refrigerate protect from light"],"version":"7","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 the 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 for the purpose of making your child sleepy Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as chronic bronchitis chronic cough that lasts, or as occurs with asthma cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product, do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. 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 (1-800-222-1222) right away."],"when_using":["When using this product, do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children sedatives and tranquilizers may increase drowsiness"]}