{"active_ingredient":["Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant"],"active_ingredient_table":["
Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Phenylephrine HCl 2.5 mgNasal decongestant
"],"ask_doctor":["Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) 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 = milliliters repeat dose every 4 hours do not give 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":["
Age (yr)Dose (mL)
under 4 yearsdo not use
4 to 5 years5 mL
6 to 11 years10 mL
"],"effective_time":"20241112","id":"23508e92-0823-8827-e063-6394a90aeb9d","inactive_ingredient":["Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose"],"indications_and_usage":["Uses temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies: cough nasal congestion 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 Cold plus Cough"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-785-04"],"product_ndc":["50580-785"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1544873"],"spl_id":["23508e92-0823-8827-e063-6394a90aeb9d"],"spl_set_id":["20e45243-3989-413a-bcf1-49d754ff2e44"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","04JA59TNSJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50580-785-04 children's SUDAFED ® PE non-drowsy COLD + COUGH Phenylephrine HCl • Dextromethorphan HBr Nasal Decongestant • Cough Suppressant Oral Solution RELIEF OF Stuffy Nose Sinus Pressure Cough Grape FLAVOR LIQUID ALCOHOL & SUGAR FREE 4 fl oz (118 mL) PRINCIPAL DISPLAY PANEL"],"purpose":["Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant"],"purpose_table":["
Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Phenylephrine HCl 2.5 mgNasal decongestant
"],"questions":["Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)"],"set_id":"20e45243-3989-413a-bcf1-49d754ff2e44","spl_product_data_elements":["Childrens SUDAFED PE Cold plus Cough Dextromethorphan hydrobromide and Phenylephrine hydrochloride ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SOLUTION SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"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 cough gets worse or lasts for more than 7 days cough tends to come back or occurs with fever, rash or headache that lasts These could be signs of a serious condition."],"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":"12","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 persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) 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 cough gets worse or lasts for more than 7 days cough tends to come back or occurs with fever, rash or headache that lasts 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 right away. (1-800-222-1222)"],"when_using":["When using this product do not exceed recommended dose"]}