{"active_ingredient":["Active ingredients (in each 5 mL) Purposes Diphenhydramine HCl 12.5 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant"],"active_ingredient_table":["
Active ingredients (in each 5 mL)Purposes
Diphenhydramine HCl 12.5 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant
"],"ask_doctor":["Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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 find right dose on chart below mL = milliliter take every 4 hours do not take more than 6 doses in 24 hours Age (yr) Dose (mL) children under 4 years do not use children 4 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL adults and children 12 years and over 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)
children under 4 yearsdo not use
children 4 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years5 mL
adults and children 12 years and over10 mL
"],"effective_time":"20241108","id":"21e89245-b2fa-5dd2-e063-6294a90a7795","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 hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion stuffy nose temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion stuffy nose 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 Benadryl Allergy Plus Congestion"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-341-01"],"product_ndc":["50580-341"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086720","1086723"],"spl_id":["21e89245-b2fa-5dd2-e063-6294a90a7795"],"spl_set_id":["b8b75904-3806-4258-89c1-d6ff486ed41c"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["TC2D6JAD40","04JA59TNSJ"],"upc":["0300450170057"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50580-341-01 Children's Benadryl ® ALLERGY PLUS CONGESTION Diphenhydramine HCl / antihistamine Phenylephrine HCl / nasal decongestant oral solution 4 Hours/Dose RELIEF OF: Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat or Nose Sinus Congestion Stuffy Nose Alcohol Free Sugar Free ALLERGY + CONGESTION RELIEF Grape! Flavored Liquid 4 fl oz (118 mL) Principal Display Panel"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 5 mL) Purposes Diphenhydramine HCl 12.5 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant"],"purpose_table":["
Active ingredients (in each 5 mL)Purposes
Diphenhydramine HCl 12.5 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant
"],"questions":["Questions or comments? call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)"],"set_id":"b8b75904-3806-4258-89c1-d6ff486ed41c","spl_product_data_elements":["Childrens Benadryl Allergy Plus Congestion Diphenhydramine hydrochloride 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 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 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"],"storage_and_handling":["Other information each 5 mL contains: sodium 10 mg store between 20-25°C (68-77°F) do not use if carton tape or bottle wrap imprinted with \"Sealed For Your Safety\" is broken or missing"],"version":"9","warnings":["Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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 trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not exceed recommended dose marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever 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. (1-800-222-1222)"],"when_using":["When using this product do not exceed recommended dose marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"]}