{"active_ingredient":["Active ingredient (in each 5 mL = 1 teaspoon) Purpose Diphenhydramine HCl, USP 6.25 mg Antihistamine/Cough suppressant Phenylephrine HCl, USP 2.5 mg Nasal decongestant"],"active_ingredient_table":["
Active ingredient (in each 5 mL = 1 teaspoon) Purpose
Diphenhydramine HCl, USP 6.25 mg Antihistamine/Cough suppressant
Phenylephrine HCl, USP 2.5 mg Nasal decongestant
"],"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 pharmacist before use if the child is taking sedatives or tranquilizers.","Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product. Age (yr) Dose (TSP) TSP = teaspoon under 6 yrs. ask a doctor 6 to under 12 2 TSP or as directed by a doctor"],"ask_doctor_or_pharmacist_table":["
Age (yr) Dose (TSP)
TSP = teaspoon
under 6 yrs. ask a doctor
6 to under 12 2 TSP
or as directed by a doctor
"],"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 use more than 6 times in 24 hours use only enclosed dosing cup to dose this product. Do not use any other dosing device."],"effective_time":"20130206","id":"9eaf18d1-da77-46e4-9730-3671f8529fb6","inactive_ingredient":["Inactive ingredients artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C blue #1, FD&C red #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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label ACCU DIAL ® Children's Nite Time Cold and Cough Diphenhydramine (Antihistamine/Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Cough • Runny Nose Stuffy Nose • Itchy Throat Earth-Friendly Package! For Ages 6 yrs to under 12 yrs Tamper Evident Compares to Children's Triaminic ® Night Time Cold & Cough GRAPE FLAVOR NDC 45014-159-04 4 FL. OZ. (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label"],"purpose":["Active ingredient (in each 5 mL = 1 teaspoon) Purpose Diphenhydramine HCl, USP 6.25 mg Antihistamine/Cough suppressant Phenylephrine HCl, USP 2.5 mg Nasal decongestant"],"purpose_table":["
Active ingredient (in each 5 mL = 1 teaspoon) Purpose
Diphenhydramine HCl, USP 6.25 mg Antihistamine/Cough suppressant
Phenylephrine HCl, USP 2.5 mg Nasal decongestant
"],"questions":["Questions? 877-434-2036"],"set_id":"b41f9c5b-8671-43f0-acd1-1b21051246ec","spl_product_data_elements":["Nite Time Cold and Cough Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine 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":["Drug Facts","Distributed by: AccuDial® Pharmaceutical, Inc. Palm Beach Gardens, FL 33408"],"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 teaspoon contains: sodium 9 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing."],"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 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. Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product. Age (yr) Dose (TSP) TSP = teaspoon under 6 yrs. ask a doctor 6 to under 12 2 TSP or as directed by a doctor Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms."],"warnings_table":["
Age (yr) Dose (TSP)
TSP = teaspoon
under 6 yrs. ask a doctor
6 to under 12 2 TSP
or as directed by a doctor
"],"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."]}