{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 20 } }, "results": [ { "spl_product_data_elements": [ "topcare all day allergy d cetirizine hydrochloride, pseudoephedrine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE L147" ], "active_ingredient": [ "Active ingredients (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg" ], "purpose": [ "Purpose Antihistamine Nasal decongestant" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • nasal congestion • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose" ], "warnings": [ "Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • 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 • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: 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 have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • 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 • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose." ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "when_using": [ "When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery" ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: 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 • do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor 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 overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.adults 65 years and overask a doctorchildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
" ], "storage_and_handling": [ "Other information • store between 20° to 25°C (68° to 77°F) • do not use if blister unit is broken or torn • see side panel for lot number and expiration date • meets USP Dissolution Test 2" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide" ], "questions": [ "Questions or comments? 1-888-423-0139" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel TopCare ® health COMPARE TO ZYRTEC-D ® ACTIVE INGREDIENTS ORIGINAL PRESCRIPTION STRENGTH ALLERGY & SINUS All Day Allergy-D CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLETS, 5 mg/120 mg INDOOR & OUTDOOR ALLERGIES 12 HOUR RELIEF NASAL CONGESTION + SINUS PRESSURE • Sneezing • Itchy, Watery Eyes • Runny Nose • Itchy Nose or Throat 24 EXTENDED RELEASE TABLETS actual size topcare-all-day-allergy-d-carton-image.jpg" ], "set_id": "103df878-1455-414f-94cb-5b32a2d3e4b8", "id": "66a3abdd-101b-4ab7-a9de-373339ccc794", "effective_time": "20250212", "version": "5", "openfda": { "application_number": [ "ANDA210719" ], "brand_name": [ "topcare all day allergy d" ], "generic_name": [ "CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE" ], "manufacturer_name": [ "Topco Associates LLC" ], "product_ndc": [ "36800-744" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CETIRIZINE HYDROCHLORIDE", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "1014571" ], "spl_id": [ "66a3abdd-101b-4ab7-a9de-373339ccc794" ], "spl_set_id": [ "103df878-1455-414f-94cb-5b32a2d3e4b8" ], "package_ndc": [ "36800-744-62" ], "is_original_packager": [ true ], "unii": [ "64O047KTOA", "6V9V2RYJ8N" ] } } ] }