{"active_ingredient":["Active ingredients (in each 5 mL) Purpose Diphenhydramine HCl 12.5 mg Antihistamine/Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant"],"active_ingredient_table":["<table width=\"70%\"> <col width=\"52%\" align=\"left\" valign=\"top\"/> <col width=\"48%\" align=\"right\" valign=\"top\"/> <thead> <tr styleCode=\"toprule\"> <th> <content styleCode=\"italics\">Active ingredients (in each 5 mL)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr styleCode=\"toprule\"> <td>Diphenhydramine HCl 12.5 mg</td> <td>Antihistamine/Cough suppressant</td> </tr> <tr styleCode=\"botrule\"> <td>Phenylephrine HCl 5 mg</td> <td>Nasal decongestant</td> </tr> </tbody> </table>"],"ask_doctor":["Ask a doctor before use if you have heart disease diabetes high blood pressure thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus)"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"do_not_use":["Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on the skin if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions do not take more than directed do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter Age (year) Dose (mL) adults and children 12 years of age and over 10 mL every 4 hours children 6 to under 12 years of age 5 mL every 4 hours 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":["<table width=\"50%\"> <col width=\"48%\" align=\"left\" valign=\"top\"/> <col width=\"52%\" align=\"left\" valign=\"top\"/> <thead> <tr> <th align=\"center\" styleCode=\"Lrule Rrule\">Age (year)</th> <th align=\"center\" styleCode=\"Rrule\">Dose (mL)</th> </tr> </thead> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">adults and children 12 years of age and over</td> <td styleCode=\"Rrule\">10 mL every 4 hours</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">children 6 to under 12 years of age</td> <td styleCode=\"Rrule\">5 mL every 4 hours</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">children 4 to under 6 years of age </td> <td styleCode=\"Rrule\">do not use unless directed by a doctor</td> </tr> <tr> <td styleCode=\"Lrule Rrule\">children under 4 years of age </td> <td styleCode=\"Rrule\">do not use</td> </tr> </tbody> </table>"],"effective_time":"20150416","id":"8f300bcd-9bd7-4a33-a44b-8f84180eb4ae","inactive_ingredient":["Inactive ingredients anhydrous citric acid, anhydrous trisodium citrate, carboxymethylcellulose sodium, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose"],"indications_and_usage":["Uses temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itchy nose or throat"],"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 - 118 mL Carton SEE NEW INGREDIENTS Delsym ® Children's NIGHT TIME COUGH & COLD Diphenhydramine HCl (Cough Suppressant/Antihistamine) Phenylephrine HCl (Nasal Decongestant) ✓ Cough ✓ Runny Nose ✓ Stuffy Nose ✓ Sneezing Grape Flavored Liquid 118 mL (4 fl oz) Principal Display Panel - 118 mL Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 5 mL) Purpose Diphenhydramine HCl 12.5 mg Antihistamine/Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant"],"purpose_table":["<table width=\"70%\"> <col width=\"52%\" align=\"left\" valign=\"top\"/> <col width=\"48%\" align=\"right\" valign=\"top\"/> <thead> <tr styleCode=\"toprule\"> <th> <content styleCode=\"italics\">Active ingredients (in each 5 mL)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr styleCode=\"toprule\"> <td>Diphenhydramine HCl 12.5 mg</td> <td>Antihistamine/Cough suppressant</td> </tr> <tr styleCode=\"botrule\"> <td>Phenylephrine HCl 5 mg</td> <td>Nasal decongestant</td> </tr> </tbody> </table>"],"questions":["Questions? 1-888-963-3382 You may also report side effects to this phone number."],"set_id":"eb4f3a43-52a3-4f6f-8280-fe1ce730de7e","spl_product_data_elements":["Delsym Childrens Night Time Cough and Cold Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine anhydrous citric acid anhydrous trisodium citrate carboxymethylcellulose sodium edetate disodium FD&C Blue No. 1 FD&C Red No. 40 glycerin propyl gallate propylene glycol water sodium benzoate sorbitol sucralose"],"spl_unclassified_section":["Drug Facts","Dist. by: Reckitt Benckiser Inc. Parsippany, NJ 07054-0224"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition."],"storage_and_handling":["Other information each 5 mL contains: sodium 10 mg tamper evident: do not use if neckband on bottle cap is broken or missing dosing cup provided store between 15-30°C (59-86°F) Keep carton for full directions for use"],"version":"5","warnings":["Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on the skin if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease diabetes high blood pressure thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast feeding, ask a health professional before use. 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 use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery"]}