{ "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": 22 } }, "results": [ { "spl_product_data_elements": [ "loratadine D loratadine, Pseudoephedrine sulfate LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED TITANIUM DIOXIDE to off-white 7U0" ], "active_ingredient": [ "Active ingredients (in each tablet) Loratadine 5 mg Pseudoephedrine sulfate 120 mg" ], "purpose": [ "Purpose Antihistamine Nasal decongestant" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • 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 • 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 • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs 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 have ever had an allergic reaction to this product or any of its ingredients • 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 • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs" ], "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 • do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours 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 over1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
" ], "other_safety_information": [ "Other information • each tablet contains: calcium 25 mg • do not use if blister unit is broken or torn • store between 20° to 25°C (68° to 77°F) • keep in a dry place" ], "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Compare to Claritin-D ® 12 Hour active ingredients Loratadine-D 12 Hour Pseudoephedrine Sulfate 120 mg / Loratadine 5 mg Extended Release Tablets Nasal Decongestant / Antihistamine Relief of: • Nasal and Sinus Congestion Due to Colds or Allergies • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Due to Allergies Indoor & Outdoor Allergies 12 Hour Allergy & Congestion 20 Tablets Non-Drowsy* *When taken as directed. See Drug Facts Panel. actual size Padagis ® padagis-loratadine-d-carton-image.jpg" ], "set_id": "01e61c73-3b81-4683-b1a9-8784c0d565b1", "id": "64fa8aa8-ec51-4129-88d1-b1a8651061f6", "effective_time": "20250303", "version": "5", "openfda": { "application_number": [ "ANDA076050" ], "brand_name": [ "loratadine D" ], "generic_name": [ "LORATADINE, PSEUDOEPHEDRINE SULFATE" ], "manufacturer_name": [ "Padagis Israel Pharmaceuticals Ltd" ], "product_ndc": [ "45802-122" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LORATADINE", "PSEUDOEPHEDRINE SULFATE" ], "rxcui": [ "1242399" ], "spl_id": [ "64fa8aa8-ec51-4129-88d1-b1a8651061f6" ], "spl_set_id": [ "01e61c73-3b81-4683-b1a9-8784c0d565b1" ], "package_ndc": [ "45802-122-46", "45802-122-60", "45802-122-65" ], "is_original_packager": [ true ], "unii": [ "7AJO3BO7QN", "Y9DL7QPE6B" ] } } ] }