{"active_ingredient":["A ctive ingredients (in each 5 mL )* Diphenhydramine HCl 12.5 mg","A ctive ingredients (in each 5 mL )* Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough accompanied by excessive phlegm (mucus) a breathing problem such as chronic bronchitis glaucoma"],"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 to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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"],"dosage_and_administration":["Directions find right dose on chart below use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. take every 4 hours do not take more than 6 doses in 24 hours Age (yr) Dose (tsp) Under 4 years Do not use 4 to 5 years Do not use unless directed by a doctor 6 to 11 years 1 teaspoonful Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device."],"dosage_and_administration_table":["<table> <col width=\"259\"/> <col width=\"379\"/> <tbody> <tr> <td styleCode=\"     Toprule          Rrule     \"> <content styleCode=\"bold\">Age (yr)</content> </td> <td styleCode=\"     Toprule         Lrule     \"> <content styleCode=\"bold\">Dose (tsp)</content> </td> </tr> <tr> <td styleCode=\"     Toprule          Rrule     \"> Under 4 years</td> <td styleCode=\"     Toprule         Lrule     \"> Do not use</td> </tr> <tr> <td styleCode=\"     Toprule          Rrule     \"> 4 to 5 years</td> <td styleCode=\"     Toprule         Lrule     \"> Do not use unless directed by a doctor</td> </tr> <tr> <td styleCode=\"     Toprule          Rrule     \"> 6 to 11 years</td> <td styleCode=\"     Toprule         Lrule     \"> 1 teaspoonful</td> </tr> </tbody> </table>"],"effective_time":"20100806","id":"5e6660e6-3fe5-41da-8135-d2f47fab98ca","inactive_ingredient":["Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes nasal congestion itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion cough"],"keep_out_of_reach_of_children":["Keep out of reach of chi ldren 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 See New Warnings & Directions PediaCare Children’s Allergy & Cold Phenylephrine HCI, Diphenhydramine HCI 4 FL OZ (118 mL ) PRINCIPAL DISPLAY PANEL PediaCare Children’s Allergy & Cold Phenylephrine HCI, Diphenhydramine HCI 4 FL OZ (118 mL)"],"purpose":["Purposes Antihistamine/cough suppressant","Purposes Nasal decongestant *5 mL = one teaspoon"],"questions":["Questions or comments? call 1-888-474-3099"],"set_id":"e349f954-c331-4493-ae0b-543af66bd1ae","spl_product_data_elements":["PediaCare Childrens Allergy and Cold Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE"],"spl_unclassified_section":["PediaCare Children’s Allergy & Cold Drug Facts","Other information each teaspoon contains: sodium 10 mg store between 20-25°C (68-77°F). Protect from light. do not use if bottle wrap, or foil inner seal imprinted “Safety Seal®” is broken or missing see bottom panel for lot number and expiration date Store in outer carton until contents are used."],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever cough gets worse or lasts for more than 7 days cough tends to come back or occurs with fever, rash or headache that lasts These could be signs of a serious condition."],"version":"4","warnings":["Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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 Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough accompanied by excessive phlegm (mucus) a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product do not exceed recommended dose excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever cough gets worse or lasts for more than 7 days cough tends to come back or occurs with fever, rash or headache that lasts These could be signs of a serious condition. Keep out of reach of chi ldren 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 dose excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness"]}