{"active_ingredient":["Active ingredients (in each 5 mL, 1 teaspoonful) Purposes Diphenhydramine HCl 6.25 mg Antihistamine/Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant"],"active_ingredient_table":["<table width=\"70%\"> <col width=\"50%\" align=\"left\" valign=\"bottom\"/> <col width=\"50%\" align=\"right\" valign=\"bottom\"/> <thead> <tr styleCode=\"Toprule\"> <th> <content styleCode=\"bold italics\">Active ingredients  (in each 5 mL, 1 teaspoonful)</content> </th> <th> <content styleCode=\"bold italics\">Purposes</content> </th> </tr> </thead> <tbody> <tr styleCode=\"Toprule\"> <td valign=\"top\">Diphenhydramine HCl 6.25 mg</td> <td>Antihistamine/Cough suppressant</td> </tr> <tr styleCode=\"Botrule\"> <td>Phenylephrine HCl 2.5 mg</td> <td>Nasal decongestant</td> </tr> </tbody> </table>"],"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 6 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 may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor. to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age. specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device. children under 6 years of age do not use children 6 to under 12 years of age 1-2 tsp. (5-10 mL)"],"dosage_and_administration_table":["<table width=\"60%\"> <col width=\"60%\" align=\"center\" valign=\"top\"/> <col width=\"40%\" align=\"center\" valign=\"top\"/> <tbody> <tr styleCode=\"Toprule\"> <td styleCode=\"Botrule\">children under 6 years of age</td> <td styleCode=\"Lrule Botrule\">do not use</td> </tr> <tr styleCode=\"Botrule\"> <td>children 6 to under 12 years of age</td> <td styleCode=\"Lrule\">1-2 tsp. (5-10 mL)</td> </tr> </tbody> </table>"],"effective_time":"20091111","id":"2d46d37d-abad-4b65-a19c-69d843ea6662","inactive_ingredient":["Inactive ingredients artificial flavor, benzoic acid, citric acid, disodium edetate, FD&C blue no. 1, FD&C red no. 40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol."],"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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Carton CHILDREN'S ACCU DIAL ROTATING DOSING LABEL Nite Time Cold & Cough ACCURATE DOSING BY WEIGHT Diphenhydramine HCl (Antihistamine/Cough Suppressant Phenylephrine HCl (Nasal Decongestant) Cough Relief Runny, Stuffy Nose Itchy Throat For Ages 6 to under 12 Compares to Children's Triaminic ® Night Time Cold & Cough. GRAPE FLAVOR 4 FL. OZ. (118 mL) NDC 45014-154-04 Principal Display Panel - 118 mL Carton"],"purpose":["Active ingredients (in each 5 mL, 1 teaspoonful) Purposes Diphenhydramine HCl 6.25 mg Antihistamine/Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant"],"purpose_table":["<table width=\"70%\"> <col width=\"50%\" align=\"left\" valign=\"bottom\"/> <col width=\"50%\" align=\"right\" valign=\"bottom\"/> <thead> <tr styleCode=\"Toprule\"> <th> <content styleCode=\"bold italics\">Active ingredients  (in each 5 mL, 1 teaspoonful)</content> </th> <th> <content styleCode=\"bold italics\">Purposes</content> </th> </tr> </thead> <tbody> <tr styleCode=\"Toprule\"> <td valign=\"top\">Diphenhydramine HCl 6.25 mg</td> <td>Antihistamine/Cough suppressant</td> </tr> <tr styleCode=\"Botrule\"> <td>Phenylephrine HCl 2.5 mg</td> <td>Nasal decongestant</td> </tr> </tbody> </table>"],"questions":["Questions? 877-434-2036"],"set_id":"64dd0b21-21c5-4d45-ac7f-9896c2a033b0","spl_product_data_elements":["Nite Time Cold and Cough Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine Grape Benzoic Acid Citric Acid Monohydrate Edetate Disodium FD&C BLUE NO. 1 FD&C RED NO. 40 Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol"],"spl_unclassified_section":["NITE TIME COLD & COUGH Drug Facts"],"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 teaspoonful contains: sodium 4 mg store at controlled room temperature 20°-25°C (68°-77°F)"],"version":"1","warnings":["Warnings Do not use in a child under 6 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 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 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 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 right away."],"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"]}