{"active_ingredient":["Active ingredient (in each tablet) Phenylephrine HCl 10 mg","Active ingredients (in each tablet) Purpose Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 10 mg Nasal decongestant"],"active_ingredient_table":["
Active ingredients (in each tablet)Purpose
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 10 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","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 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.","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 adults and children 12 years and over take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours children under 12 years ask a doctor","Directions adults and children 12 years and over take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours children under 12 years ask a doctor"],"dosage_and_administration_table":["
adults and children 12 years and overtake 1 tablet every 4 hoursdo not take more than 6 tablets in 24 hours
children under 12 yearsask a doctor
","
adults and children 12 years and overtake 1 tablet every 4 hoursdo not take more than 6 tablets in 24 hours
children under 12 yearsask a doctor
"],"effective_time":"20241108","id":"216dcbdd-8eff-4427-e063-6294a90aed52","inactive_ingredient":["Inactive ingredients carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide","Inactive ingredients carnauba wax, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies","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 temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion 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)","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":["SUDAFED PE SINUS CONGESTION"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-239-01"],"product_ndc":["50580-239"],"product_type":["HUMAN OTC DRUG"],"rxcui":["1049182","1052767","1052928","2639176"],"spl_id":["216dcbdd-8eff-4427-e063-6294a90aed52"],"spl_set_id":["a38fdfb8-db89-487f-9b68-aa9152b91f5f"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL PREVIOUSLY SUDAFED PE ® DAY + NIGHT SINUS CONGESTION NDC 50580-239-01 SUDAFED PE® SINUS CONGESTION Phenylephrine HCl Nasal Decongestant DAYTIME NASAL CONGESTION actual size 12 TABLETS 10 mg each Diphenhydramine HCl, Phenylephrine HCl Antihistamine, Nasal Decongestant NIGHTTIME NASAL CONGESTION RUNNY NOSE actual size 8 TABLETS | TOTAL: 20 TABLETS Principal Display Panel"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use.","If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant","Active ingredients (in each tablet) Purpose Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 10 mg Nasal decongestant"],"purpose_table":["
Active ingredients (in each tablet)Purpose
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 10 mgNasal decongestant
"],"questions":["Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)","Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)"],"set_id":"a38fdfb8-db89-487f-9b68-aa9152b91f5f","spl_product_data_elements":["SUDAFED PE SINUS CONGESTION diphenhydramine hydrochloride and phenylephrine hydrochloride Sudafed PE Siinus Congestion Phenylephrine Hydrochloride CARNAUBA WAX D&C YELLOW NO. 10 ALUMINUM LAKE FD&C RED NO. 40 FD&C YELLOW NO. 6 ALUMINUM OXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POWDERED CELLULOSE SODIUM STARCH GLYCOLATE TYPE A TALC TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WL;80;PE SUDAFED PE SINUS CONGESTION PLUS ALLERGY Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride CARNAUBA WAX FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POWDERED CELLULOSE SODIUM STARCH GLYCOLATE TYPE A TALC TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PE;WL95"],"spl_unclassified_section":["SUDAFED PE ® DAYTIME Drug Facts","SUDAFED PE ® NIGHTTIME 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","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 store between 20-25°C (68-77°F) do not use if blister unit is torn or broken","Other information store between 20-25°C (68-77°F) do not use if blister unit is torn or broken"],"version":"5","warnings":["Warnings Do not use 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 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 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)","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","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"]}