{"active_ingredient":["ACTIVE INGREDIENTS (IN EACH TABLET) Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg"],"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."],"dosage_and_administration":["DIRECTIONS do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["
adults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"effective_time":"20250908","id":"3e4ab498-9f9e-bd3b-e063-6294a90a9b9c","inactive_ingredient":["INACTIVE INGREDIENTS calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and 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 reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose"],"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":["ANDA076557"],"brand_name":["Loratadine and Pseudoephedrine Sulfate"],"generic_name":["LORATADINE AND PSEUDOEPHEDRINE SULFATE"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"package_ndc":["0904-5833-15","0904-5833-48"],"product_ndc":["0904-5833"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1117562"],"spl_id":["3e4ab498-9f9e-bd3b-e063-6294a90a9b9c"],"spl_set_id":["2620a150-4a2c-4fa2-a0e4-6aafe9e496c3"],"substance_name":["LORATADINE","PSEUDOEPHEDRINE SULFATE"],"unii":["7AJO3BO7QN","Y9DL7QPE6B"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 240 mg/10 mg Tablet Blister Pack Carton MAJOR ® NDC 0904-5833-15 compare to the active ingredients in Claritin-D ® 24 Hour** non-drowsy* loratadine-D original prescription strength pseudoephedrine sulfate, USP 240 mg nasal decongestant loratadine, USP 10 mg antihistamine 24 hour indoor & outdoor allergies allergy & congestion relief of: nasal and sinus congestion due to colds or allergies sneezing; runny nose; itchy, watery eyes; itchy throat or nose due to allergies *when taken as directed. see drug facts panel. 10 extended-release tablets lorad"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PURPOSE Antihistamine Nasal decongestant"],"questions":["QUESTIONS? call 1-800-406-7984 Keep the carton. It contains important information. See end panel for expiration date."],"set_id":"2620a150-4a2c-4fa2-a0e4-6aafe9e496c3","spl_product_data_elements":["Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN PROPYLENE GLYCOL SHELLAC SODIUM ALGINATE SODIUM CITRATE, UNSPECIFIED FORM TALC TITANIUM DIOXIDE CALCIUM CARBONATE SILICON DIOXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE white to off-white RX724"],"spl_unclassified_section":["OTHER INFORMATION sodium: contains 10 mg/tablet calcium: contains 25 mg/tablet TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only) store between 20° C to 25° C (68° F to 77° F). protect from light and store in a dry place","Distributed By MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com"],"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"],"version":"5","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)."],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}