{"active_ingredient":["Drug Facts Active ingredient (in each tablet) Pseudoephedrine Hydrochloride USP 240 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 had obstruction or narrowing of the bowel Rarely, tablets of this kind may cause bowel obstruction (blockage), usually in people with severe narrowing of the bowel (esophagus, stomach or intestine)."],"dosage_and_administration":["Directions adults and children 12 years and over swallow one whole tablet with water every 24 hours do not exceed one tablet in 24 hours do not divide, crush, chew or dissolve the tablet the tablet does not completely dissolve and may be seen in the stool (this is normal) children under 12 years do not use this product in children under 12 years of age"],"dosage_and_administration_table":["
adults and children 12 years and over swallow one whole tablet with water every 24 hoursdo not exceed one tablet in 24 hoursdo not divide, crush, chew or dissolve the tabletthe tablet does not completely dissolve and may be seen in the stool (this is normal)
children under 12 years do not use this product in children under 12 years of age
"],"effective_time":"20260106","id":"77e4132e-470e-4fb4-bc2f-df2e59061ba9","inactive_ingredient":["Inactive ingredients black iron oxide, cellulose acetate, colloidal silicon dioxide, dibutyl sebacate, glyceryl mono and dicaprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide. Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009"],"indications_and_usage":["Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages relieves sinus 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":["ANDA218854"],"brand_name":["Pseudoephedrine Hydrochloride"],"generic_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"package_ndc":["58602-884-58","58602-884-27"],"product_ndc":["58602-884"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049670"],"spl_id":["77e4132e-470e-4fb4-bc2f-df2e59061ba9"],"spl_set_id":["77e4132e-470e-4fb4-bc2f-df2e59061ba9"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 5 Blister Carton Label AUROHEALTH NDC 58602-884-58 # Compare to the active ingredient in Sudafed ® Sinus Congestion 24 Hour. Pseudoephedrine Hydrochloride Extended-Release Tablets, USP 240 mg Nasal Decongestant MAXIMUM STRENGTH 24 HOUR • SINUS PRESSURE + CONGESTION • NON-DROWSY Actual Size 2 x 5 tablets per blister card PPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 5 Blister Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant"],"set_id":"77e4132e-470e-4fb4-bc2f-df2e59061ba9","spl_product_data_elements":["Pseudoephedrine Hydrochloride pseudoephedrine hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE FERROSOFERRIC OXIDE CELLULOSE ACETATE SILICON DIOXIDE DIBUTYL SEBACATE GLYCERYL MONO- AND DICAPRYLOCAPRATE HYPROMELLOSE 2208 (100000 MPA.S) HYPROMELLOSE 2910 (3 MPA.S) LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POLYVINYL ALCOHOL, UNSPECIFIED PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE white to off-white biconvex P240"],"spl_unclassified_section":["Other information store at 20° to 25°C (68° to 77°F). do not use if the individual blister unit is open or torn see side panel for lot number and expiration date FDA approved dissolution test specifications differ from USP."],"stop_use":["nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever you experience persistent abdominal pain or vomiting"],"version":"1","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."],"when_using":["When using this product do not exceed recommended dosage Stop use and ask a doctor if"]}