{"active_ingredient":["Active ingredient (in each 5 mL, 1 teaspoon) Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg"],"ask_doctor":["Ask a doctor before use if the child has glaucoma heart disease high blood pressure diabetes thyroid disease 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 to make a child sleepy 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 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"],"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. if needed, repeat dose every 4 hours do not give more than 6 times in 24 hours unless directed by a doctor tsp = teaspoon; mL = milliliter Age (yr) Dose (tsp or mL) under 4 years do not use 4 to 5 years do not use unless directed by a doctor 6 to 11 years 2 teaspoonfuls (10 mL)"],"dosage_and_administration_table":["
Age (yr) Dose (tsp or mL)
under 4 years do not use
4 to 5 years do not use unless directed by a doctor
6 to 11 years 2 teaspoonfuls (10 mL)
"],"effective_time":"20171025","id":"45589fef-379a-42aa-a343-9f60cda2630d","inactive_ingredient":["Inactive ingredients acesulfame potassium, benzoic acid, citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavor, maltitol solution, propylene glycol, purified water, sodium citrate"],"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."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel CHILDREN Ages 6-11 PediaCare Childrens NIGHTTIME MULTI-SYMPTOM Cold Relieves Stuffy Nose Soothes Itchy Throat Controls Cough Diphenhydramine HCl Antihistamine/Cough suppressant Phenylephrine HCl Nasal decongestant Grape Flavor FL OZ (mL) TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING KEEP THIS BOX FOR COMPLETE INSTRUCTIONS. Distributed by Medtech Products Inc. Irvington, NY 10533, a Prestige Brands Company Made in USA www.PediaCare.com","Package Label PediaCare Childrens Nighttime Multi-Symptom Cold Grape Liquid Diphenhydramine HCl 6.25 mg; Phenylephrine HCl 2.5 mg"],"purpose":["Purpose Antihistamine/Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-888-474-3099"],"set_id":"e9432ccf-e0c6-4286-82f2-5a6a10bb5893","spl_product_data_elements":["PediaCare Childrens Nighttime Multi Symptom Cold diphenhydramine, phenylephrine DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM BENZOIC ACID ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 MALTITOL PROPYLENE GLYCOL WATER SODIUM CITRATE"],"spl_unclassified_section":["Other information each teaspoon (5 mL) contains: sodium 6 mg store at room temperature. Protect from light. Store in outer carton until contents are used. see bottom panel for lot number and expiration date"],"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."],"version":"2","warnings":["Warnings Do not use to make a child sleepy 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 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 Ask a doctor before use if the child has glaucoma heart disease high blood pressure diabetes thyroid disease 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 dose 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."],"when_using":["When using this product do not exceed recommended dose marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children"]}