{"active_ingredient":["Active ingredient (in each tablet) Guaifenesin 200mg"],"dosage_and_administration":["Directions: Do not take more than 6 doses in any 24-hour period. This product is not intended for use in children under 12 years of age Adults & children 12 years and over: 1 to 2 tablets every 4 hours Children under 12 years: do not use"],"effective_time":"20250109","id":"2b4b8161-b037-f244-e063-6294a90ae372","inactive_ingredient":["Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev: 02/19TCL"],"indications_and_usage":["Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive"],"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":{"application_number":["M012"],"brand_name":["Guaifenesin 200mg"],"generic_name":["GUAIFENESIN"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"original_packager_product_ndc":["10135-681"],"package_ndc":["71610-434-18"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["71610-434"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["197741"],"spl_id":["2b4b8161-b037-f244-e063-6294a90ae372"],"spl_set_id":["45ac210a-8c54-4469-8e10-e6fe52b89cb5"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 200 mg NDC 71610-434 - Guaifenesin 200 mg Tablets Bottle Label 200 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast- feeding , ask a health professional before use."],"purpose":["Purpose Expectorant Guaifenesin 200 mg Tablets"],"safe_handling_warning":["Other Information: Store at 15°C-30°C (59°F-86°F)"],"set_id":"45ac210a-8c54-4469-8e10-e6fe52b89cb5","spl_product_data_elements":["Guaifenesin 200mg Guaifenesin SILICON DIOXIDE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONE STEARIC ACID GUAIFENESIN GUAIFENESIN G2"],"spl_unclassified_section":["GUAIFENESIN 200 MG TABLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact","Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 200 mg 3000 71610-434-18 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20200619JH Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["<table border=\"0\" cellpadding=\"1\" cellspacing=\"1\" width=\"28%\"><col width=\"10%\"/><col/><tbody><tr styleCode=\"Toprule\"><td align=\"center\" styleCode=\"bold\" valign=\"bottom\">Count</td><td align=\"center\" valign=\"bottom\"><content styleCode=\"bold\">200 mg</content></td></tr><tr><td align=\"center\" valign=\"bottom\">3000</td><td align=\"center\">71610-434-18</td></tr></tbody></table>"],"stop_use":["Stop use and ask a doctor if cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING."],"version":"2","warnings":["Warnings Ask a doctor before use if you have Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. 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."]}