{"active_ingredient":["Active ingredient (in each tablet) Pseudoephedrine HCl 30 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 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours children ages 6 to 11 years • take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"37%\"/><col width=\"53%\"/><tbody><tr><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>take 2 tablets every 4 to 6 hours</item><item><caption>&#x2022;</caption>do not take more than 8 tablets in 24 hours</item></list></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>children ages 6 to 11 years</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>take 1 tablet every 4 to 6 hours</item><item><caption>&#x2022;</caption>do not take more than 4 tablets in 24 hours</item></list></td></tr><tr><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>children under 6 years</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>do not use this product in children under 6 years of age</paragraph></td></tr></tbody></table>"],"effective_time":"20241107","how_supplied":["HOW SUPPLIED Product: 50090-4345 NDC: 50090-4345-1 1 TABLET, FILM COATED in a BLISTER PACK / 24 in a CARTON"],"id":"72064c3e-8348-4230-b2e3-47a03e3467df","inactive_ingredient":["Inactive ingredients carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, 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":["SUDOGEST NASAL DECONGESTANT"],"generic_name":["PSEUDOEPHEDRINE HCL"],"manufacturer_name":["A-S Medication Solutions"],"original_packager_product_ndc":["0904-6337"],"package_ndc":["50090-4345-1","50090-4345-0","50090-4345-2","50090-4345-3","50090-4345-4","50090-4345-5"],"product_ndc":["50090-4345"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049160","1049162"],"spl_id":["72064c3e-8348-4230-b2e3-47a03e3467df"],"spl_set_id":["09feb5f0-c22d-4a1b-97a0-d5767e5f7730"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N"]},"package_label_principal_display_panel":["Pseudoephedrine HCl Label Image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant"],"questions":["Questions or comments? 1-800-616-2471"],"set_id":"09feb5f0-c22d-4a1b-97a0-d5767e5f7730","spl_product_data_elements":["SUDOGEST NASAL DECONGESTANT Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE COPERNICIA CERIFERA (CARNAUBA) WAX DICALCIUM PHOSPHATE DIHYDRATE HYDROXYPROPYL METHYLCELLULOSE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED PEG-20 SORBITAN OLEATE SILICA CI 77891 CURRY RED convex L432"],"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 tablet contains: calcium 20 mg • store at 20 ° -25 ° C (68 ° -77 ° F) • do not use if blister unit is broken or torn"],"version":"10","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 dosage 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 dosage"]}