{"active_ingredient":["Active Ingredients (in each TSP (5 mL)) Purposes Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCL 2.5 mg Nasal decongestant"],"active_ingredient_table":["<table width=\"75%\"> <col width=\"60%\" align=\"left\" valign=\"top\"/> <col width=\"40%\" align=\"right\" valign=\"top\"/> <thead> <tr styleCode=\"Toprule\"> <th> <content styleCode=\"italics\">Active Ingredients (in each TSP (5 mL))</content> </th> <th> <content styleCode=\"italics\">Purposes</content> </th> </tr> </thead> <tbody> <tr styleCode=\"Toprule\"> <td>Dextromethorphan HBr 5 mg</td> <td>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 cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma"],"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."],"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 1 TSP (5 mL) Children 6 to under 12 years of age 2 TSP (10 mL)"],"dosage_and_administration_table":["<table width=\"75%\"> <col width=\"60%\" align=\"left\" valign=\"top\"/> <col width=\"40%\" align=\"left\" valign=\"top\"/> <thead> <tr styleCode=\"Botrule\"> <th styleCode=\"Lrule Rrule\">Age</th> <th styleCode=\"Rrule\">Dose</th> </tr> <tr> <th styleCode=\"Lrule Rrule\">Children under 4 years of age</th> <th styleCode=\"Rrule\">Do not use</th> </tr> </thead> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">Children 4 to under 6 years of age</td> <td styleCode=\"Rrule\">1 TSP (5 mL)</td> </tr> <tr> <td styleCode=\"Lrule Rrule\">Children 6 to under 12 years of age</td> <td styleCode=\"Rrule\">2 TSP (10 mL)</td> </tr> </tbody> </table>"],"effective_time":"20180824","id":"9fd49567-10e2-4d46-a2ec-0cd53a937f95","inactive_ingredient":["Inactive Ingredients benzoic acid, citric acid anhydrous, EDTA disodium dihydrate, FD&C red #40, flavor, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol"],"indications_and_usage":["Uses Temporarily relieves: nasal & 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 59741-201-06 ASSURED ® Day Time Cold & Cough * Cough Suppressant: Dextromethorphan HBr Nasal Decongestant: Phenylephrine HCl Relief for: • Cough• Stuffy Nose Cherry Flavor 4 FL OZ (118 mL) Principal Display Panel - 118 mL Bottle Label"],"purpose":["Active Ingredients (in each TSP (5 mL)) Purposes Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCL 2.5 mg Nasal decongestant"],"purpose_table":["<table width=\"75%\"> <col width=\"60%\" align=\"left\" valign=\"top\"/> <col width=\"40%\" align=\"right\" valign=\"top\"/> <thead> <tr styleCode=\"Toprule\"> <th> <content styleCode=\"italics\">Active Ingredients (in each TSP (5 mL))</content> </th> <th> <content styleCode=\"italics\">Purposes</content> </th> </tr> </thead> <tbody> <tr styleCode=\"Toprule\"> <td>Dextromethorphan HBr 5 mg</td> <td>Cough suppressant</td> </tr> <tr styleCode=\"Botrule\"> <td>Phenylephrine HCL 2.5 mg</td> <td>Nasal decongestant</td> </tr> </tbody> </table>"],"set_id":"0badeec0-552d-49bd-8681-7949b828be21","spl_product_data_elements":["Assured Day time Cold and Cough Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Hydrochloride Phenylephrine saccharin sodium Citric Acid Monohydrate FD&C Red no. 40 benzoic acid Water Edetic Acid Sodium Citrate Sorbitol Propylene Glycol Prunus Serotina Bark"],"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 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 TSP contains: sodium 2 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. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma When using this product do not exceed recommended dosage 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 (1-800-222-1222) right away."],"when_using":["When using this product do not exceed recommended dosage"]}