{"active_ingredient":["Active ingredient (in each tablet) Phenylephrine HCl 10 mg"],"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"],"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."],"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"],"dosage_and_administration_table":["<table width=\"50%\" styleCode=\"Noautorules\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Toprule Rrule\">adults and children 12 years and over</td><td styleCode=\"Toprule\"><list listType=\"unordered\" styleCode=\"Square\"><item>take 1 tablet every 4 hours</item><item>do not take more than 6 tablets in 24 hours</item></list></td></tr><tr><td styleCode=\"Rrule\">children under 12 years</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20241108","id":"21ad7bba-a836-8d9d-e063-6294a90a371d","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"],"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"],"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":["Sudafed PE Sinus Congestion"],"generic_name":["PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-437-01","50580-437-02","50580-437-03"],"product_ndc":["50580-437"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049182","1052767"],"spl_id":["21ad7bba-a836-8d9d-e063-6294a90a371d"],"spl_set_id":["2ca08917-1a75-4365-8520-c083e6a4225a"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE"],"unii":["04JA59TNSJ"],"upc":["0300450581365"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL PREVIOUSLY SUDAFED PE ® CONGESTION NDC 50580-437-02 SUDAFED PE® SINUS CONGESTION Phenylephrine HCl, Nasal Decongestant actual size MAXIMUM STRENGTH SINUS PRESSURE SINUS CONGESTION 36 TABLETS NON-DROWSY 10 mg each Principal Display Panel"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant"],"questions":["Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)"],"set_id":"2ca08917-1a75-4365-8520-c083e6a4225a","spl_product_data_elements":["Sudafed PE Sinus Congestion Phenylephrine Hydrochloride CARNAUBA WAX D&C YELLOW NO. 10 ALUMINUM LAKE ALUMINUM OXIDE FD&C RED NO. 40 FD&C YELLOW NO. 6 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"],"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 store between 20-25°C (68-77°F) do not use if blister unit is torn or broken"],"version":"6","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)"],"when_using":["When using this product do not exceed recommended dose"]}