{"active_ingredient":["Active ingredients (in each 15 mL (TBSP)) Phenylephrine HCl 10 mg Thonzylamine HCl 50 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to the enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"do_not_use":["Do not use this product if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions Do not exceed recommended dosage. Use enclosed dosage cup or tablespoon (TBSP). Adults and children 12 years of age and over: 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period. Children 6 to under 12 years of age: 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period. Children under 6 years of age: Consult a doctor."],"dosage_and_administration_table":["<table><col width=\"312\"/><col width=\"312\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \">Adults and children  12 years of age  and over:  </td><td styleCode=\"Toprule Lrule Rrule \">15 mL (1 TBSP) every 4 hours,  not to exceed 90 mL (6 TBSP) in a  24 hour period.  </td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Children 6 to under  12 years of age:  </td><td styleCode=\"Toprule Lrule Rrule \">7.5 mL (1/2 TBSP) every 4 hours,  not to exceed 45 mL (3 TBSP) in a  24 hour period.  </td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Children under  6 years of age:  </td><td styleCode=\"Toprule Lrule Rrule \">Consult a doctor.  </td></tr></tbody></table>"],"effective_time":"20231127","id":"0b281455-f2ce-fe79-e063-6394a90aadd6","inactive_ingredient":["Inactive ingredients citric acid anhydrous, cotton candy flavor, FD&C Red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose."],"indications_and_usage":["Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: nasal congestion reduces swelling of the nasal passages runny nose sneezing itching of the nose or throat itchy, watery eyes"],"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 right away."],"openfda":{},"other_safety_information":["Other information Each 15 mL (TBSP) contains: Sodium 6 mg. Store at 59-86°F (15-30°C)."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 58809-729-04 NasOpenPE Cotton Candy Flavor 4 fl.oz. (118 mL) PRINCIPAL DISPLAY PANEL NDC 58809-729-04 NasOpenPE Cotton Candy Flavor 4 fl.oz. (118 mL) PRINCIPAL DISPLAY PANEL NDC 58809-729-04 NasOpenPE Cotton Candy Flavor 4 fl.oz. (118 mL)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal Decongestant Antihistamine"],"questions":["Questions? Comments? Call 1-888-535-0305 9 a.m. - 5 p.m. CST. R100716"],"set_id":"5e133352-255f-41cc-aacc-0508d634368d","spl_product_data_elements":["Nasopen PE Phenylephrine Hydrochloride, Thonzylamine Hydrochloride GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SACCHARIN SODIUM SORBITOL SUCRALOSE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE THONZYLAMINE HYDROCHLORIDE THONZYLAMINE"],"spl_unclassified_section":["Nasopen PE NDC 58809-729-04 Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Supplied in a tight, light-resistant container with a child-resistant cap. Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76015 Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not improve within 7 days or accompanied by fever. new symptoms occur"],"version":"8","warnings":["Warnings Do not exceed recommended dosage. Do not use this product if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to the enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not improve within 7 days or accompanied by fever. new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery"]}