{"active_ingredient":["Active ingredient (in each tablet) Pseudoephedrine HCl 30 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 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours children ages 6 to 11 years • take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"20%\"/><col width=\"79%\"/><tbody><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>take 2 tablets every 4 to 6 hours</item><item><caption>&#x2022;</caption>do not take more than 8 tablets in 24 hours</item></list></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children ages 6 to 11 years</paragraph></td><td styleCode=\"Lrule Toprule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>take 1 tablet every 4 to 6 hours</item><item><caption>&#x2022;</caption>do not take more than 4 tablets in 24 hours</item></list></td></tr><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>children under 6 years</paragraph></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>do not use this product in children under 6 years of age</paragraph></td></tr></tbody></table>"],"effective_time":"20240816","id":"c25dd71c-bfa6-45c6-a4f0-a46919acf185","inactive_ingredient":["Inactive ingredients carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies"],"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":["M012"],"brand_name":["pseudoephedrine hydrochloride"],"generic_name":["PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Padagis Israel Pharmaceuticals Ltd"],"package_ndc":["45802-432-62"],"product_ndc":["45802-432"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049160"],"spl_id":["c25dd71c-bfa6-45c6-a4f0-a46919acf185"],"spl_set_id":["458594e1-8d99-4de3-8923-2fd8ce2fc406"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N"]},"package_label_principal_display_panel":["Principal Display Panel Compare to Sudafed ® Congestion active ingredient Pseudoephedrine Hydrochloride, 30 mg Nasal Decongestant MAXIMUM STRENGTH • SINUS PRESSURE • SINUS CONGESTION 24 TABLETS actual size NON-DROWSY Padagis ™ PSEUDOEPHEDRINE HYDROCHLORIDE CARTON IMAGE 1 OF 2 PSEUDOEPHEDRINE HYDROCHLORIDE CARTON IMAGE 2 OF 2"],"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":"458594e1-8d99-4de3-8923-2fd8ce2fc406","spl_product_data_elements":["pseudoephedrine hydrochloride Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CARNAUBA WAX DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SILICON DIOXIDE TITANIUM DIOXIDE FD&C RED NO. 40 ALUMINUM LAKE convex L432"],"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 20 mg • store at 20 ° -25 ° C (68 ° -77 ° F) • do not use if blister unit is broken or torn"],"version":"7","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"]}