{"active_ingredient":["Active ingredient (in each tablet) Pseudoephedrine HCl 120 mg"],"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"],"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."],"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":["<table width=\"100%\"><col width=\"39%\"/><col width=\"61%\"/><tbody><tr><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>take 1 tablet every 12 hours</item><item><caption>&#x2022;</caption>do not take more than 2 tablets in 24 hours</item></list></td></tr><tr><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>children under 12 years</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>do not use this product in children under 12 years of age</paragraph></td></tr></tbody></table>"],"effective_time":"20241226","id":"a8ebb0c0-4ab7-4bf2-a8e3-09e62c3cdcd7","inactive_ingredient":["Inactive ingredients carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide"],"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"],"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)."],"openfda":{"application_number":["ANDA075153"],"brand_name":["pseudoephedrine hydrochloride"],"generic_name":["PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Padagis Israel Pharmaceuticals Ltd"],"package_ndc":["45802-107-52"],"product_ndc":["45802-107"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049154"],"spl_id":["a8ebb0c0-4ab7-4bf2-a8e3-09e62c3cdcd7"],"spl_set_id":["4a4da1e6-2ad1-47f7-a9b3-7d845962ef3b"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N"]},"package_label_principal_display_panel":["Principal Display Panel Compare to Sudafed ® Sinus Congestion 12 Hour active ingredient Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg Nasal Decongestant MAXIMUM STRENGTH • SINUS PRESSURE + CONGESTION 12 HOUR SINUS 10 COATED CAPLETS* *(Capsule-shaped Tablets) actual size NON-DROWSY Padagis ™ 054-rt-pseudoephedrine-hydrochloride-extended-release-tablets.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"4a4da1e6-2ad1-47f7-a9b3-7d845962ef3b","spl_product_data_elements":["pseudoephedrine hydrochloride Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CARNAUBA WAX SILICON DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE L054"],"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"],"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 broken or torn • see carton end panel for lot number and expiration date • this product meets the requirements of USP Drug Release Test 3"],"version":"5","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)."],"when_using":["When using this product do not exceed recommended dosage"]}