{"active_ingredient":["Active ingredients (in each extended-release tablet) Guaifenesin USP 1200 mg 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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)"],"dosage_and_administration":["Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours children under 12 years of age: do not use"],"effective_time":"20240903","id":"2fb64af9-47fb-442a-b7ee-8aae3d5b0ddb","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize)."],"indications_and_usage":["Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage 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":["ANDA213203"],"brand_name":["Guaifenesin and Pseudoephedrine HCl"],"generic_name":["GUAIFENESIN AND PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58602-834-77","58602-834-78"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58602-834"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1244675"],"spl_id":["2fb64af9-47fb-442a-b7ee-8aae3d5b0ddb"],"spl_set_id":["2f622f57-4de0-44a9-a21f-c98260574f1e"],"substance_name":["GUAIFENESIN","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["495W7451VQ","6V9V2RYJ8N"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/120 mg (12 Tablet Carton Label) AUROHEALTH NDC 58602-834-77 *Compare to the active ingredients of Mucinex ® D MAXIMUM STRENGTH Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets 1200 mg/120 mg Guaifenesin 1200 mg - Expectorant Pseudoephedrine HCl 120 mg - Nasal Decongestant RELIEVES NASAL & CHEST CONGESTION 12 HOUR • Clears Nasal & Sinus Congestion • Thins & Loosens Mucus 12 Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/120 mg (12 Tablet Carton Label)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use"],"purpose":["Purposes Expectorant Nasal Decongestant"],"questions":["Questions? 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: AP/DRUGS/04/2016"],"set_id":"2f622f57-4de0-44a9-a21f-c98260574f1e","spl_product_data_elements":["Guaifenesin and Pseudoephedrine HCl Guaifenesin and Pseudoephedrine HCl GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE HYPROMELLOSE 2208 (15000 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POVIDONE K25 POVIDONE K90 STARCH, CORN white to off-white modified, biconvex 65;X"],"stop_use":["Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness"],"storage_and_handling":["Other information store at 20 to 25°C (68 to 77°F)"],"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 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 use more than directed"]}