{"active_ingredient":["Active ingredient (in each 5 mL) Phenylephrine HCl 2.5 mg"],"ask_doctor":["Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet"],"do_not_use":["Do not use 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."],"dosage_and_administration":["Directions find right dose on chart below mL = milliliter repeat dose every 4 hours do not use more than 6 times in 24 hours Age (yr) Dose (mL) under 4 years do not use 4 to 5 years 5 mL 6 to 11 years 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device."],"dosage_and_administration_table":["<table width=\"40%\" styleCode=\"Noautorules\"><col width=\"50%\" align=\"left\" valign=\"middle\"/><col width=\"50%\" align=\"left\" valign=\"middle\"/><thead><tr styleCode=\"Botrule\"><th styleCode=\"Toprule Rrule\">Age (yr)</th><th styleCode=\"Toprule\">Dose (mL)</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">under 4 years</td><td>do not use</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">4 to 5 years</td><td>5 mL</td></tr><tr><td styleCode=\"Rrule\">6 to 11 years</td><td>10 mL</td></tr></tbody></table>"],"effective_time":"20241104","id":"23506802-1f31-c967-e063-6394a90a2e7f","inactive_ingredient":["Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose"],"indications_and_usage":["Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure"],"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. (1-800-222-1222)"],"openfda":{"application_number":["M012"],"brand_name":["Childrens Sudafed PE NASAL DECONGESTANT"],"generic_name":["PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-784-04"],"product_ndc":["50580-784"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["692479"],"spl_id":["23506802-1f31-c967-e063-6394a90a2e7f"],"spl_set_id":["4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE"],"unii":["04JA59TNSJ"],"upc":["0300450537041"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50580-784-04 children's SUDAFED ® PE non-drowsy NASAL DECONGESTANT Phenylephrine HCl Oral Solution Nasal Decongestant RELIEF OF Stuffy Nose Sinus Pressure Berry FLAVOR LIQUID ALCOHOL & SUGAR FREE 4 fl oz (118 mL) 2.5 mg per 5 mL PRINCIPAL DISPLAY PANEL"],"purpose":["Purpose Nasal decongestant"],"questions":["Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)"],"set_id":"4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d","spl_product_data_elements":["Childrens Sudafed PE NASAL DECONGESTANT Phenylephrine hydrochloride SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SOLUTION SODIUM BENZOATE SUCRALOSE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN WATER BERRY"],"spl_unclassified_section":["Drug Facts"],"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"],"storage_and_handling":["Other information each 5 mL contains: sodium 14 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used. do not use if carton tape or bottle wrap imprinted with \"Sealed For Your Safety\" is broken or missing"],"version":"11","warnings":["Warnings Do not use 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. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"when_using":["When using this product do not exceed recommended dose"]}