{"id":"pseudoephedrine","rwe":[],"_fda":{"id":"77ce98b8-4c34-41de-8d2b-45137f48a692","set_id":"00a8327b-41f0-4498-ad13-331256b539f9","openfda":{"unii":["6V9V2RYJ8N"],"route":["ORAL"],"rxcui":["1049154"],"spl_id":["77ce98b8-4c34-41de-8d2b-45137f48a692"],"brand_name":["Pseudoephedrine hydrochloride"],"spl_set_id":["00a8327b-41f0-4498-ad13-331256b539f9"],"package_ndc":["30142-967-20"],"product_ndc":["30142-967"],"generic_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"manufacturer_name":["The Kroger Company"],"application_number":["ANDA077442"],"is_original_packager":[true]},"purpose":["Purpose Nasal decongestant"],"version":"2","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"],"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)"],"questions":["Questions? 1-800-632-6900"],"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."],"when_using":["When using this product do not exceed recommended dosage"],"effective_time":"20210413","active_ingredient":["Active ingredient (in each tablet) Pseudoephedrine HCl, USP 120 mg"],"inactive_ingredient":["Inactive ingredients castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide"],"storage_and_handling":["Other information store at 59° to 77° F in a dry place. Protect from light TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING."],"indications_and_usage":["Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY THE KROGER CO. CINCINNATI, OH 45202"],"dosage_and_administration":["Directions adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age"],"spl_product_data_elements":["Pseudoephedrine hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CASTOR OIL SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE TITANIUM DIOXIDE 204"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"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)"],"dosage_and_administration_table":["<table width=\"40%\" styleCode=\"Noautorules\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults and children 12 years and over</td><td><list styleCode=\"square\" listType=\"unordered\"><item>take 1 tablet every 12 hours</item><item>do not take more than 2 tablets in 24 hours</item></list></td></tr><tr><td styleCode=\"Rrule\">children under 12 years</td><td>do not use this product in children under 12 years of age</td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 120 mg Blister Pack Carton COMPARE TO the active ingredient of SUDAFED ® 12 HOUR **See side panel NDC 30142-967-20 Kroger ® OUR PHARMACIST RECOMMENDED Maximum Strength Sinus Pseudoephedrine Hydrochloride 120 mg 12 Hour Extended-Release Tablets, USP LONG ACTING NASAL DECONGESTANT NON-DROWSY Relieves Sinus Pressure + Congestion actual size 12 HOUR 20 COATED CAPLETS* 120 mg EACH *capsule-shaped tablets PRINCIPAL DISPLAY PANEL - 120 mg Blister Pack Carton"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"7710 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"5637 reports"},{"date":"","signal":"SYSTEMIC LUPUS ERYTHEMATOSUS","source":"FDA FAERS","actionTaken":"5221 reports"},{"date":"","signal":"ABDOMINAL DISCOMFORT","source":"FDA FAERS","actionTaken":"5142 reports"},{"date":"","signal":"RHEUMATOID ARTHRITIS","source":"FDA FAERS","actionTaken":"5136 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"5123 reports"},{"date":"","signal":"PEMPHIGUS","source":"FDA FAERS","actionTaken":"5098 reports"},{"date":"","signal":"ALOPECIA","source":"FDA FAERS","actionTaken":"5013 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"4734 reports"},{"date":"","signal":"GLOSSODYNIA","source":"FDA FAERS","actionTaken":"4676 reports"}],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Achalasia of esophagus","Acidosis","Acute Thromboembolic Stroke","Acute abdominal pain","Acute exacerbation of asthma","Acute hepatitis","Acute nephropathy","Acute pancreatitis","Alcohol intoxication","Alcohol withdrawal delirium","Alcoholism","Anemia","Angina pectoris","Angle-closure glaucoma","Arterial thrombosis","Arteriosclerotic vascular disease","Asthenia","Atony of colon","Autonomic dysreflexia","Benign intracranial hypertension","Benign prostatic hyperplasia","Bladder outflow obstruction","Bleeding","Blood coagulation disorder","Body fluid retention","Bradycardia","Brain damage","Breastfeeding (mother)","Cardiovascular event risk","Central nervous system depression","Cerebrovascular accident","Chronic disease of respiratory system","Chronic heart failure","Chronic idiopathic constipation","Chronic lung disease","Chronic obstructive lung disease","Coma","Complete trisomy 21 syndrome","Conduction disorder of the heart","Constipation","Continuous fever","Cor pulmonale","Coronary arteriosclerosis","Coronary artery bypass graft","Cystic fibrosis","Decreased respiratory function","Dehydration","Dependent drug abuse","Diabetes mellitus","Disease of liver","Disorder of autonomic nervous system","Disorder of cardiovascular system","Disorder of coronary artery","Disorder of gallbladder","Disturbance of salivary secretion","Drowsy","Drug AND/OR toxin-induced diarrhea","Drug-induced psychosis","Dysfunction of sphincter of Oddi","Edema","Epilepsy","Esophageal dysmotility","Exacerbation of asthma","Fever greater than 100.4 Fahrenheit","Gastric ulcer","Gastroesophageal reflux disease","Gastrointestinal hemorrhage","Gastrointestinal obstruction","Gastrointestinal perforation","Gastrointestinal ulcer","Glaucoma","Hepatic failure","Hiatal hernia","Hypercapnia","Hyperkalemia","Hypertensive disorder","Hypertensive urgency","Hyperthyroidism","Hyporeninemic hypoaldosteronism","Hypothyroidism","Hypovolemic shock","Hypoxia","Impaired renal function disorder","Inflammatory bowel disease","Injury of head","Kidney disease","Lesion of brain","Liver function tests abnormal","Low blood pressure","Metabolic acidosis","Mood swings","Morbid obesity","Multiple organ failure","Myasthenia gravis","Myocardial dysfunction","Myocardial infarction","Neoplasm of brain","Ocular hypertension","Operation on gastrointestinal tract","Paralytic ileus","Partial atrioventricular block","Peptic reflux disease","Peptic ulcer","Poisoning by acetaminophen","Pregnancy, function","Primary adrenocortical insufficiency","Procedure on urinary system","Pseudomembranous enterocolitis","Pulmonary edema","Pulmonary emphysema","Pyloric obstruction","Retention of urine","Rhabdomyolysis","Seizure disorder","Sepsis syndrome","Severe Hypoxemia","Severe chronic ulcerative colitis","Shock","Smokes tobacco daily","Smoking cessation assistance","Spastic paralysis","Substance abuse","Suicidal thoughts","Tachyarrhythmia","Theophylline Toxicity","Third trimester pregnancy","Thromboembolic disorder","Toxic megacolon","Traumatic injury","Ulcerative colitis","Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant","Urethral stricture","Urinary tract obstruction","Ventricular tachycardia"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"approved","trials":["NCT02275364","NCT06374836","NCT01006863","NCT02048215","NCT01928797","NCT00432991","NCT02149901","NCT01133483","NCT05016076","NCT06563297","NCT01062360","NCT05993481","NCT04370847","NCT03933306","NCT00673062","NCT05874687","NCT02622126","NCT04053478","NCT02476981","NCT00441246","NCT05414877","NCT02948920","NCT02182518","NCT02658721","NCT04779528","NCT07440667","NCT05498857","NCT05135416","NCT03047109","NCT01509521","NCT04682717","NCT01132222","NCT01710722","NCT01033396","NCT05993182","NCT03984526","NCT00240812","NCT02961842","NCT00377403","NCT05382624","NCT05692869","NCT00976209","NCT03072173","NCT07123675","NCT02352545","NCT07092046","NCT00762567","NCT05697328","NCT03184766","NCT04005664"],"aliases":["Sudafed"],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost 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Kept behind pharmacy counters in the US due to methamphetamine precursor regulations. Available generically.","brandName":"Sudafed","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Alpha-1A adrenergic receptor, Alpha-2A adrenergic receptor, Beta-2 adrenergic receptor","novelty":"","modality":"Small molecule","drugClass":"Nasal decongestant (sympathomimetic)","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:08:53.036375+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic (multiple manufacturers)","competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"pseudoephedrine","indications":{"approved":[{"name":"Allergic conjunctivitis","diseaseId":"allergic-conjunctivitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Allergic 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Changes","completionDate":"2017-07-27"},{"nctId":"NCT02182518","phase":"Phase 3","title":"Double-blind, Randomized, Parallel Trial to Evaluate the Clinical Efficacy and Safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, Twice a Day, Versus Epinastine 10 mg Alone, Twice a Day, in the T","status":"COMPLETED","sponsor":"Boehringer Ingelheim","isPivotal":true,"enrollment":101,"indication":"Rhinitis, Allergic, Perennial","completionDate":""},{"nctId":"NCT02658721","phase":"Phase 3","title":"Effects of Addition of Systemic Tramadol or Adjunct Tramadol to Lidocaine Used for Intravenous Regional Anesthesia in Patients Undergoing Hand Surgery","status":"COMPLETED","sponsor":"Bagcilar Training and Research Hospital","isPivotal":true,"enrollment":60,"indication":"Anesthesia","completionDate":"2013-08"},{"nctId":"NCT04779528","phase":"NA","title":"Awake Nasal Fiber-optic Intubation of Severely Obese Patients in Lateral Position: a Prospective Randomized Controlled Trial","status":"COMPLETED","sponsor":"University of Jordan","isPivotal":false,"enrollment":60,"indication":"Anesthesia, Intubation;Difficult","completionDate":"2022-02-21"},{"nctId":"NCT07440667","phase":"NA","title":"A Prospective Randomized Controlled Trial Comparing Restrictive and Liberal Intraoperative Fluid Strategies on Postoperative Nausea and Vomiting and Gastrointestinal Recovery After Elective Cesarean S","status":"RECRUITING","sponsor":"Nigde Omer Halisdemir University","isPivotal":false,"enrollment":160,"indication":"Cesarean Section, Postoperative Nausea and Vomiting (PONV)","completionDate":"2027-01-30"},{"nctId":"NCT05498857","phase":"Phase 4","title":"Intramuscular Ephedrine in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Prospective, Randomized, Double-blind, Placebo-controlled Trial","status":"UNKNOWN","sponsor":"Hospital de Base","isPivotal":false,"enrollment":202,"indication":"Ephedrine, Intramuscular","completionDate":"2023-07"},{"nctId":"NCT05135416","phase":"NA","title":"The Impact of Chewing Gum on Postoperative Bowel Activity and Postoperative Pain After Total Laparoscopic Hysterectomy","status":"COMPLETED","sponsor":"Kanuni Sultan Suleyman Training and Research Hospital","isPivotal":false,"enrollment":92,"indication":"Postoperative Pain","completionDate":"2021-09-01"},{"nctId":"NCT03047109","phase":"Phase 2","title":"Ephedrine Versus Phenylephrine Infusion for Prevention of Spinal Hypotension During Cesarean Section: Effect on Maternal Cardiodynamics and Fetal Circulation: Randomized Double-blind Study","status":"COMPLETED","sponsor":"Assiut University","isPivotal":true,"enrollment":60,"indication":"Spinal Hypotension","completionDate":"2020-03-30"},{"nctId":"NCT01509521","phase":"Phase 4","title":"The Oxygenation of the Brain During Caesarean Section. 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