{ "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": "2026-06-03", "results": { "skip": 0, "limit": 1, "total": 178 } }, "results": [ { "spl_product_data_elements": [ "Pseudoephedrine hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CASTOR OIL SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE TITANIUM DIOXIDE 204" ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY THE KROGER CO. CINCINNATI, OH 45202" ], "active_ingredient": [ "Active ingredient (in each tablet) Pseudoephedrine HCl, USP 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 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." ], "inactive_ingredient": [ "Inactive ingredients castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide" ], "questions": [ "Questions? 1-800-632-6900" ], "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" ], "set_id": "00a8327b-41f0-4498-ad13-331256b539f9", "id": "77ce98b8-4c34-41de-8d2b-45137f48a692", "effective_time": "20210413", "version": "2", "openfda": { "application_number": [ "ANDA077442" ], "brand_name": [ "Pseudoephedrine hydrochloride" ], "generic_name": [ "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "manufacturer_name": [ "The Kroger Company" ], "product_ndc": [ "30142-967" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "1049154" ], "spl_id": [ "77ce98b8-4c34-41de-8d2b-45137f48a692" ], "spl_set_id": [ "00a8327b-41f0-4498-ad13-331256b539f9" ], "package_ndc": [ "30142-967-20" ], "is_original_packager": [ true ], "unii": [ "6V9V2RYJ8N" ] } } ] }