{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-14", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Sudafed Sinus Congestion 12 Hour Pseudoephedrine Hydrochloride CARNAUBA WAX SILICA CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE HYDROXYPROPYL METHYLCELLULOSE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED PEG-20 SORBITAN OLEATE CI 77891 PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SU12" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredient (in each tablet) Pseudoephedrine HCl 120 mg" ], "purpose": [ "Purpose Nasal decongestant" ], "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" ], "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)." ], "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." ], "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" ], "when_using": [ "When using this product do not exceed recommended dosage" ], "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" ], "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": [ "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" ], "dosage_and_administration_table": [ "
adults and children 12 years and overtake 1 tablet every 12 hoursdo not take more than 2 tablets in 24 hours
children under 12 yearsdo not use this product in children under 12 years of age
" ], "storage_and_handling": [ "Other information each tablet contains: calcium 45 mg store at 20-25°C (68-77°F) in a dry place protect from light do not use if blister unit is torn or broken see carton end panel for lot number and expiration date this product meets the requirements of USP Drug Release Test 3" ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide" ], "questions": [ "Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)" ], "how_supplied": [ "HOW SUPPLIED Product: 50090-4629 NDC: 50090-4629-0 10 TABLET, FILM COATED, EXTENDED RELEASE in a BLISTER PACK / 1 in a CARTON" ], "package_label_principal_display_panel": [ "Pseudoephedrine Hydrochloride Label Image" ], "set_id": "0e4717a1-914b-466d-8bf0-d37ebc32fdb3", "id": "51527d7c-26f4-4538-928e-f3ac2bba4f84", "effective_time": "20250915", "version": "12", "openfda": { "application_number": [ "ANDA075153" ], "brand_name": [ "Sudafed Sinus Congestion 12 Hour" ], "generic_name": [ "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "manufacturer_name": [ "A-S Medication Solutions" ], "product_ndc": [ "50090-4629" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "1049154", "1049668" ], "spl_id": [ "51527d7c-26f4-4538-928e-f3ac2bba4f84" ], "spl_set_id": [ "0e4717a1-914b-466d-8bf0-d37ebc32fdb3" ], "package_ndc": [ "50090-4629-0" ], "original_packager_product_ndc": [ "50580-242" ], "unii": [ "6V9V2RYJ8N" ] } } ] }