{"active_ingredient":["Active Ingredients (in each TSP (5 mL)) Purposes Diphenhydramine HCL 6.25 mg Antihistamine/cough suppressant Phenylephrine HCL 2.5 mg Nasal decongestant"],"active_ingredient_table":["
Active Ingredients (in each TSP (5 mL)) Purposes
Diphenhydramine HCL 6.25 mg Antihistamine/cough suppressant
Phenylephrine HCL 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 a doctor before use if the child is taking sedatives or tranquilizers"],"do_not_use":["Do not use 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 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 Age Dose Children under 4 years of age Do not use Children 4 to under 6 years of age Do not use unless directed by doctor Children 6 to under 12 years of age 2 TSP (10 mL)"],"dosage_and_administration_table":["
Age Dose
Children under 4 years of age Do not use
Children 4 to under 6 years of age Do not use unless directed by doctor
Children 6 to under 12 years of age 2 TSP (10 mL)
"],"effective_time":"20180824","id":"19581687-27fb-4180-9f3e-72ec2d877166","inactive_ingredient":["Inactive Ingredients benzoic acid, citric acid anhydrous, EDTA disodium dihydrate, FD&C blue #1, FD&C red #40, flavor, 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 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 (1-800-222-1222) right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 59741-202-06 ASSURED ® Night Time Cold & Cough * Antihistamine/Cough Suppressant: Diphenhydramine HCl Nasal Decongestant: Phenylephrine HCl Relief for: • Itchy Throat • Runny Nose • Stuffy Nose • Cough Grape Flavor 4 FL OZ (118 mL) Principal Display Panel - 118 mL Bottle Label"],"purpose":["Active Ingredients (in each TSP (5 mL)) Purposes Diphenhydramine HCL 6.25 mg Antihistamine/cough suppressant Phenylephrine HCL 2.5 mg Nasal decongestant"],"purpose_table":["
Active Ingredients (in each TSP (5 mL)) Purposes
Diphenhydramine HCL 6.25 mg Antihistamine/cough suppressant
Phenylephrine HCL 2.5 mg Nasal decongestant
"],"set_id":"7d21d66d-095f-44a7-aacd-3d464aeb5ba8","spl_product_data_elements":["Assured Night time Cold and Cough Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine saccharin sodium Citric Acid Monohydrate FD&C Red no. 40 benzoic acid Water EDETIC ACID Sodium Citrate Sorbitol Propylene Glycol FD&C BLUE NO. 1 Vitis Vinifera Fruit Oil"],"spl_unclassified_section":["Drug Facts","Manufactured by: Bio-Pharm, Inc. Levittown, PA 19057"],"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 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 TSP contains: sodium 9 mg store at 20°-25°C (68°-77°F) TAMPER EVIDENT: Do no use if foil seal over mouth of the bottle is torn, broken or missing."],"version":"2","warnings":["Warnings Do not use 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 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 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 occur 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 (1-800-222-1222) 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"]}