{"active_ingredient":["Active ingredient (in each tablet) Pseudoephedrine HCl USP 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 cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"100%\"><colgroup><col width=\"34%\"/><col width=\"65%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 12 years and over<content styleCode=\"bold\"><content styleCode=\"italics\"/></content> </td><td styleCode=\"Rrule\" valign=\"top\"><list listType=\"unordered\" styleCode=\"disc\"><item>take 1 tablet every 12 hours </item><item>do not take more than 2 tablets in 24 hours<content styleCode=\"bold\"><content styleCode=\"italics\"/></content></item></list></td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"top\">children under 12 years<content styleCode=\"bold\"><content styleCode=\"italics\"/></content> </td><td styleCode=\"Rrule\" valign=\"top\">do not use this product in children under 12 years of age </td></tr></tbody></table>"],"effective_time":"20240724","id":"14aa89a7-5eb1-4037-a169-cbb527b46e95","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and 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":["ANDA209008"],"brand_name":["Pseudoephedrine HCl"],"generic_name":["PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Better Living Brands LLC"],"package_ndc":["21130-158-67"],"product_ndc":["21130-158"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049154"],"spl_id":["14aa89a7-5eb1-4037-a169-cbb527b46e95"],"spl_set_id":["f9d5a22a-3964-08b8-e053-6294a90ab220"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N"],"upc":["0387730788560"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets Compare to the Sudafed ® 12 Hour** active ingredient NDC 21130-158-67 12 HOUR MAXIMUM STRENGTH Long-Acting Nasal Decongestant PSEUDOEPHEDRINE HCl Extended-Release Tablets USP 120 mg • SINUS PRESSURE • CONGESTION • NON-DROWSY 20 COATED CAPLETS* 120 mg EACH *CAPSULE-SHAPED TABLETS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant"],"questions":["Questions or comments? call 1-855-274-4122 DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O.BOX 99 PLEASANTON, CA 94566-0009 ‡1-888-723-3929 Made in India Code: TS/DRUGS/22/2009"],"set_id":"f9d5a22a-3964-08b8-e053-6294a90ab220","spl_product_data_elements":["Pseudoephedrine HCl Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE 2208 (15000 MPA.S) HYPROMELLOSE 2208 (4000 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE TALC TITANIUM DIOXIDE White to Off-white 70;T"],"spl_unclassified_section":["Drug Facts"],"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 36 mg store at 20° to 25°C (68° to 77°F). Protect from light. do not use if the individual blister unit is open or torn see side panel for lot number and expiration date Meets USP dissolution test 4"],"version":"2","warnings":["Warnings"],"when_using":["When using this product do not exceed recommended dosage"]}