{"active_ingredient":["Active ingredient (in each tablet) Guaifenesin 400mg"],"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":"20251113","id":"437e33ae-1e1d-56a8-e063-6294a90abc66","inactive_ingredient":["Inactive Ingredients: Maltodextrin, Povidone, Silicon Dioxide, Stearic acid. Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 03/24 AA"],"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 400mg"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Marlex Pharmaceuticals Inc"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["10135-790-30","10135-790-60"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["10135-790"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["359601"],"spl_id":["437e33ae-1e1d-56a8-e063-6294a90abc66"],"spl_set_id":["13f4db4e-687e-9d7b-e063-6294a90ab088"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 10135-0790-30 Guaifenesin 400 mg 30 CAPLETS 790-30","PRINCIPAL DISPLAY PANEL NDC 10135-0790-60 Guaifenesin 400 mg 60 CAPLETS 790-60"],"pregnancy_or_breast_feeding":["If pregnant or breast- feeding, ask a health professional before use."],"purpose":["Purpose Expectorant Guaifenesin 4 00 mg Caplets"],"safe_handling_warning":["Other Information: Store at 15°C-30°C (59°F-86°F)"],"set_id":"13f4db4e-687e-9d7b-e063-6294a90ab088","spl_product_data_elements":["Guaifenesin 400mg Guaifenesin SILICON DIOXIDE MALTODEXTRIN POVIDONE STEARIC ACID GUAIFENESIN GUAIFENESIN White to off white C16 Caplet"],"spl_unclassified_section":["GUAIFENESIN 400 MG CAPLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact"],"stop_use":["Stop use and ask a doctor if cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These 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, comes back or is accompanied by fever, rash, or persistent headache. These 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."]}