{"active_ingredient":["Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg"],"ask_doctor":["Ask a doctor before use if you have • heart disease • diabetes • thyroid disease • high blood pressure • 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 2 for 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 older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 12 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 cellpadding=\"0pt\" cellspacing=\"0pt\" width=\"100%\"><col width=\"49%\"/><col width=\"49%\"/><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph>adults and children 12 years and older  </paragraph></td><td styleCode=\"Lrule Toprule \" valign=\"top\"><paragraph>take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours </paragraph></td></tr><tr><td valign=\"top\"><paragraph>children ages 6 to 12 years</paragraph></td><td styleCode=\"Lrule \" valign=\"top\"><paragraph>take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours </paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>children under 6 years </paragraph></td><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>do not use this product in children under 6 years of age </paragraph></td></tr></tbody></table>"],"effective_time":"20241001","id":"6266dca3-12ba-4247-9429-dda8f1e605ee","inactive_ingredient":["Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin"],"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."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel NDC 7105-133-24 *Compare to the active ingredient in Sudafed® Congestion FOR PHARMACY USE ONLY. NOT FOR RETAIL SALE. Non-Drowsy SudoGest™ NASAL DECONGESTANT Pseudoephedrine Hydrochloride 30 mg Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness 24 TABLETS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed ® Congestion. 50844 REV0712L11212 Distributed by MAJOR® PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA M-17 Rev. 08/13 Re-Order No. 700321 Relabeled By; Proficient Rx LP Thousand Oaks CA 91320 71205-133-24"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant"],"questions":["Questions or comments? (800) 616-2471"],"set_id":"654a0b48-1461-4d4d-be0a-f821bb1a931d","spl_product_data_elements":["SudoGest Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE TRIACETIN ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C RED NO. 40 MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE 44;112"],"spl_unclassified_section":["Other information • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • see end flap for expiration date and lot number"],"stop_use":["Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with fever"],"version":"4","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 2 for 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 • diabetes • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose. Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with 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."],"when_using":["When using this product do not exceed recommended dose."]}