{"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"],"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=\"29%\"/> <col width=\"59%\"/> <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":"20190523","id":"dcfaf9dd-eada-4fd1-84f0-ef0bc2dc5029","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":["12 Hour Nasal Decongestant"],"generic_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["CVS Pharmacy"],"package_ndc":["59779-703-60","59779-703-52"],"product_ndc":["59779-703"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049154"],"spl_id":["dcfaf9dd-eada-4fd1-84f0-ef0bc2dc5029"],"spl_set_id":["85955336-3f79-457d-822c-f8be019729d1"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N"]},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredient in Sudafed® Sinus Congestion 12 Hour Caplets Non-Drowsy Sinus 12 Hour Nasal Decongestant PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 120 mg NASAL DECONGESTANT MAXIMUM STRENGTH Sinus Pressure Congestion 12 HOUR 10 COATED CAPLETS* *Capsule-shaped tablets Actual Size 054-17-12-hour-nasal-decongestant.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":"85955336-3f79-457d-822c-f8be019729d1","spl_product_data_elements":["12 Hour Nasal Decongestant Pseudoephedrine Hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CARNAUBA WAX SILICON DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 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":"6","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"]}