{"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=\"60%\" styleCode=\"Noautorules\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Toprule Rrule\">adults and children 12 years and over</td><td styleCode=\"Toprule\"><list listType=\"unordered\" styleCode=\"Square\"><item>take 1 tablet every 12 hours</item><item>do not take more than 2 tablets in 24 hours</item></list></td></tr><tr><td styleCode=\"Rrule\">children under 12 years</td><td>do not use this product in children under 12 years of age</td></tr></tbody></table>"],"effective_time":"20220908","id":"e82adca0-4a86-e2ad-e053-2a95a90ab2cf","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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL SINUS NDC 50580-342-02 SUDAFED ® 12 HOUR Pseudoephedrine HCl Extended-Release Tablets, 120 mg Long-Acting Nasal Decongestant SINUS PRESSURE + CONGESTION Pseudoephedrine HCl 20 COATED CAPLETS* 120 mg EACH MAXIMUM STRENGTH NON-DROWSY *CAPSULE-SHAPED TABLETS ‡ Actual Size PRINCIPAL DISPLAY PANEL"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant"],"questions":["Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)"],"set_id":"51bb5e49-6ae1-4321-865d-d7cff1e0097c","spl_product_data_elements":["SUDAFED 12 HOUR Pseudoephedrine Hydrochloride CARNAUBA WAX SILICON DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SU12"],"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 45 mg store at 20-25°C (68-77°F) in a dry place protect from light do not use if blister unit is torn or broken see carton end panel for lot number and expiration date this product meets the requirements of USP Drug Release Test 3"],"version":"2","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"]}