{ "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": 10 } }, "results": [ { "spl_product_data_elements": [ "Allergy relief-D Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STEARIC ACID TITANIUM DIOXIDE AMMONIA FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL BUTYL ALCOHOL PROPYLENE GLYCOL SHELLAC HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) circular 915" ], "spl_unclassified_section": [ "Drug Facts", "Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087" ], "active_ingredient": [ "Active ingredients (in each extended-release tablet) Purpose Cetirizine HCl, USP 5 mg Antihistamine Pseudoephedrine HCl, USP 120 mg Nasal Decongestant" ], "active_ingredient_table": [ "
Active ingredients (in each extended-release tablet) Purpose
Cetirizine HCl, USP 5 mg Antihistamine
Pseudoephedrine HCl, USP 120 mg Nasal Decongestant
" ], "purpose": [ "Active ingredients (in each extended-release tablet) Purpose Cetirizine HCl, USP 5 mg Antihistamine Pseudoephedrine HCl, USP 120 mg Nasal Decongestant" ], "purpose_table": [ "
Active ingredients (in each extended-release tablet) Purpose
Cetirizine HCl, USP 5 mg Antihistamine
Pseudoephedrine HCl, USP 120 mg 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 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) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter 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. at 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) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter 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. at 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 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
" ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) do not use if carton is opened or if the blister unit is broken see side panel for batch number and expiration date" ], "inactive_ingredient": [ "Inactive ingredients hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze" ], "questions": [ "Questions? Call toll free 1-800-818-4555 weekdays" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton *COMPARE TO THE ACTIVE INGREDIENTS IN ZYRTEC-D 12 HOUR ® Original Prescription Strength Premier Value ® Allergy & Congestion Relief Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor & Outdoor Allergies 12 Hour Relief of: ✓ Runny Nose ✓ Itchy Throat or Nose ✓ Sneezing ✓ Sinus Pressure ✓ Itchy, Watery Eyes ✓ Nasal Congestion 24 TABLETS (4 blister cards of 6 tablets each) INDEPENDENTLY TESTED PV SATISFACTION GUARANTEED Principal Display Panel - 24 Tablet Blister Pack Carton" ], "set_id": "0f5de86d-1c87-4664-83f6-4c17f78f7d35", "id": "d2448d3f-a6f0-47c9-bf63-0a4bcdaf0ae4", "effective_time": "20181130", "version": "1", "openfda": { "application_number": [ "ANDA090922" ], "brand_name": [ "Allergy relief-D" ], "generic_name": [ "CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE" ], "manufacturer_name": [ "CHAIN DRUG CONSORTIUM,LLC" ], "product_ndc": [ "68016-531" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CETIRIZINE HYDROCHLORIDE", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "1014571" ], "spl_id": [ "d2448d3f-a6f0-47c9-bf63-0a4bcdaf0ae4" ], "spl_set_id": [ "0f5de86d-1c87-4664-83f6-4c17f78f7d35" ], "package_ndc": [ "68016-531-24" ], "is_original_packager": [ true ], "unii": [ "64O047KTOA", "6V9V2RYJ8N" ] } } ] }