{"id":"pseudoephedrine-sulfate","_fda":{"id":"64fa8aa8-ec51-4129-88d1-b1a8651061f6","set_id":"01e61c73-3b81-4683-b1a9-8784c0d565b1","openfda":{"unii":["7AJO3BO7QN","Y9DL7QPE6B"],"route":["ORAL"],"rxcui":["1242399"],"spl_id":["64fa8aa8-ec51-4129-88d1-b1a8651061f6"],"brand_name":["loratadine D"],"spl_set_id":["01e61c73-3b81-4683-b1a9-8784c0d565b1"],"package_ndc":["45802-122-46","45802-122-60","45802-122-65"],"product_ndc":["45802-122"],"generic_name":["LORATADINE, PSEUDOEPHEDRINE SULFATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["LORATADINE","PSEUDOEPHEDRINE SULFATE"],"manufacturer_name":["Padagis Israel Pharmaceuticals Ltd"],"application_number":["ANDA076050"],"is_original_packager":[true]},"purpose":["Purpose Antihistamine Nasal decongestant"],"version":"5","stop_use":["Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs"],"warnings":["Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • 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 • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs 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 or comments? 1-800-719-9260"],"ask_doctor":["Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose."],"do_not_use":["Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • 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 take more than directed. Taking more than directed may cause drowsiness."],"effective_time":"20250303","active_ingredient":["Active ingredients (in each tablet) Loratadine 5 mg Pseudoephedrine sulfate 120 mg"],"inactive_ingredient":["Inactive ingredients croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose"],"other_safety_information":["Other information • each tablet contains: calcium 25 mg • do not use if blister unit is broken or torn • store between 20° to 25°C (68° to 77°F) • keep in a dry place"],"dosage_and_administration":["Directions • do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"spl_product_data_elements":["loratadine D loratadine, Pseudoephedrine sulfate LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED TITANIUM DIOXIDE to off-white 7U0"],"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":["
adults and children 12 years and over1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"package_label_principal_display_panel":["Package/Label Principal Display Panel Compare to Claritin-D ® 12 Hour active ingredients Loratadine-D 12 Hour Pseudoephedrine Sulfate 120 mg / Loratadine 5 mg Extended Release Tablets Nasal Decongestant / Antihistamine Relief of: • Nasal and Sinus Congestion Due to Colds or Allergies • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Due to Allergies Indoor & Outdoor Allergies 12 Hour Allergy & Congestion 20 Tablets Non-Drowsy* *When taken as directed. See Drug Facts Panel. actual size Padagis ® padagis-loratadine-d-carton-image.jpg"]},"safety":{"boxedWarnings":[]},"_chembl":{"chemblId":"CHEMBL3989855","moleculeType":"Small molecule","molecularWeight":"428.55"},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PSEUDOEPHEDRINE SULFATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T04:04:29.851350+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T04:05:11.075674+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T04:04:36.560102+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PSEUDOEPHEDRINE SULFATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T04:04:37.515597+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:04:28.739740+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:05:05.292601+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:04:28.739770+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Norepinephrine transporter releasing agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:04:38.990879+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3989855/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:04:38.642474+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA076050","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:04:28.739775+00:00"}},"_dailymed":{"setId":"0ca2b074-7137-478c-b32c-67f834f6c454","title":"ALLERGY RELIEF D 12 (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]"},"aiSummary":"Pseudoephedrine sulfate is a marketed drug primarily indicated for the relief of hay fever symptoms. Its key strength lies in its well-established market presence and the key composition patent, which is set to expire in 2028. 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