{"active_ingredient":["Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the 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"],"dosage_and_administration_table":["<table width=\"400px\" cellspacing=\"0\"><col/><col/><tbody><tr><td styleCode=\" Botrule Rrule\">adults and children 12 years and over</td><td styleCode=\" Botrule\">take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours</td></tr><tr><td styleCode=\" Botrule Rrule\">children ages 6 to 11 years</td><td styleCode=\" Botrule\">take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours</td></tr><tr><td styleCode=\" Rrule\">children under 6 years</td><td>do not use </td></tr></tbody></table>"],"effective_time":"20251021","id":"a5e06aa8-2ce0-4c33-9911-cc2f4532d173","inactive_ingredient":["Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin"],"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"],"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."],"openfda":{"application_number":["M012"],"brand_name":["SudoGest"],"generic_name":["PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"package_ndc":["0904-5053-59","0904-5053-24"],"product_ndc":["0904-5053"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049160","1049162"],"spl_id":["a5e06aa8-2ce0-4c33-9911-cc2f4532d173"],"spl_set_id":["d46577aa-7fd7-2130-6ed6-4b3f7562491f"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N"],"upc":["0309045053591"]},"package_label_principal_display_panel":["Principal Display Panel NDC 0904-5053-59 MAJOR ® compare to the active ingredient in Sudafed ® Sinus Congestion* maximum strength SudoGest™ pseudoephedrine HCl 30 mg nasal decongestant relieves: sinus pressure, sinus congestion 100 tablets FOR PHARMACY USE ONLY. NOT FOR RETAIL SALE. actual size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Rev. 10/25 M-17 Re-order No. 700321 *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Sudafed ® Sinus Congestion. 50844 REV0619P11212 Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Major 44-112 Major 44-112"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant"],"questions":["Questions or comments? 1-800-426-9391"],"set_id":"d46577aa-7fd7-2130-6ed6-4b3f7562491f","spl_product_data_elements":["SudoGest Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C RED NO. 40 ALUMINUM LAKE FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TITANIUM DIOXIDE TRIACETIN 44;112"],"spl_unclassified_section":["Other information each tablet contains: calcium 15 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever"],"version":"25","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 diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the 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 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."],"when_using":["When using this product do not exceed recommended dosage."]}