{"active_ingredient":["Active ingredient (in each 5 mL) Pseudoephedrine HCl 15 mg"],"ask_doctor":["Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes"],"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 to 6 hours do not use more than 4 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=\"50%\" styleCode=\"Noautorules\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"left\" valign=\"top\"/><thead><tr styleCode=\"Botrule\"><th styleCode=\"Rrule Toprule\">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":"20241108","id":"21732f4a-40b0-b486-e063-6394a90a1536","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, poloxamer 407, polyethylene glycol, povidone K-90, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution"],"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 promotes nasal and/or sinus drainage"],"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 Nasal Decongestant"],"generic_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-536-04"],"product_ndc":["50580-536"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049143","1049770"],"spl_id":["21732f4a-40b0-b486-e063-6394a90a1536"],"spl_set_id":["52e9307b-ad38-4f65-bb2f-4fa262e82010"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50580-536-04 children's SUDAFED ® non-drowsy NASAL DECONGESTANT Pseudoephedrine HCl Oral Solution Nasal Decongestant RELIEF OF Stuffy Nose Sinus Pressure Grape FLAVOR LIQUID ALCOHOL & SUGAR FREE 4 fl oz (118 mL) 15 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":"52e9307b-ad38-4f65-bb2f-4fa262e82010","spl_product_data_elements":["Childrens Sudafed Nasal Decongestant Pseudoephedrine hydrochloride EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MENTHOL, UNSPECIFIED FORM POLOXAMER 407 POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K90 WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SOLUTION PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ANHYDROUS CITRIC ACID"],"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 5 mg store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted \"SAFETY SEAL®\" is broken or missing"],"version":"9","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 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"]}