{"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":["take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours
adults and children 12 years and over
• •
children under 12 years do not use this product in children under 12 years of age
"],"effective_time":"20181212","id":"aa33fa45-c45a-4f91-9487-81d9b5daaeb0","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 Compare to Sudafed® 12 Hour active ingredient MAXIMUM STRENGTH 12 Hour Nasal Decongestant PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLETS, 120 mg LONG-ACTING NASAL DECONGESTANT Sinus Non-Drowsy Sinus Pressure Congestion Pseudoephedrine HCl (120 mg Each) *Capsule-Shaped Tablets 12 Hour Nasal Decongestant Carton Image 1 12 Hour Nasal Decongestant Carton Image 1 12 Hour Nasal Decongestant Carton Image 2 12 Hour Nasal Decongestant Carton Image 1 12 Hour Nasal Decongestant Carton Image 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":"b46a956d-200b-42b9-b996-344d2950aea9","spl_product_data_elements":["Leader 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":"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"]}