{"id":"guaifenesin","rwe":[],"_fda":{"id":"411e99da-2482-40c7-e063-6394a90aaf80","set_id":"004d12e1-6e3d-84c8-e063-6394a90aa653","openfda":{"nui":["N0000193956","N0000008867","N0000009560"],"unii":["9D2RTI9KYH","495W7451VQ"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["411e99da-2482-40c7-e063-6394a90aaf80"],"brand_name":["Rompe Pechito DM for Kids"],"spl_set_id":["004d12e1-6e3d-84c8-e063-6394a90aa653"],"package_ndc":["58593-276-04"],"product_ndc":["58593-276"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN"],"product_type":["HUMAN OTC DRUG"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"pharm_class_epc":["Expectorant [EPC]"],"manufacturer_name":["Efficient Laboratories Inc"],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Purpose Cough Suppressant Expectorant"],"version":"5","warnings":["Warnings Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product."],"questions":["Questions or Comments? 305-805-3456 Monday - Friday 9AM to 5PM EST www.efficientlabs.com"],"ask_doctor":["Stop use and ask a doctor if  cough that occurs with too much phlegm (mucus)  persistent or chronic cough, such as occurs with asthma or chronic bronchitis. These could be signs of a serious condition.","Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough, such as occurs with asthma or chronic bronchitis"],"do_not_use":["Do not use Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product."],"effective_time":"20251014","active_ingredient":["Active Ingredients: (in each teaspoonful 2.5 ml.) Purpose Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant Guaifenesin 50 mg ................................................................... Expectorant"],"inactive_ingredient":["Inactive Ingredients: Inactive Ingredients: citric acid, elderberry fruit extract, glycerin, honey, maltodextrin, methylparaben, flavor, potassium sorbate as a preservative, propylparaben, propylene glycol, purified water, sodium chloride, sucralose and zinc sulfate."],"indications_and_usage":["Uses Uses: temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes."],"other_safety_information":["Other Information store this product between 15 to 30 °C (59 to 86 °F ) do not refrigerate product color & flavor may vary due to natural honey Tamper-Evident Feature: do not use this product if printed security seal is torn, broken or missing."],"dosage_and_administration":["Directions Do not give more than 6 doses in any 24 hours period  shake well before use  measure only with dosing cup provided  keep dosing cup with product  mL = milliliter Age Dose Children 6 to under 12 years of age 5 mL every 4 hours Children 4 to under 6 years of age 2.5 mL every 4 hours Children under 4 years of age Do not use"],"spl_product_data_elements":["Rompe Pechito DM for Kids Dextromethorphan HBr, Guaifenesin SUCRALOSE ANHYDROUS CITRIC ACID AMERICAN ELDERBERRY MALTODEXTRIN METHYLPARABEN HONEY POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CHLORIDE ZINC SULFATE GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN"],"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."],"package_label_principal_display_panel":["Rompe Pechito Pack"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"21634 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"18205 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"15121 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"14941 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"14276 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"13405 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"12964 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"12333 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"10779 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urgency","Hyperthyroidism","Hypocalcemia","Hyporeninemic hypoaldosteronism","Hypothyroidism","Hypoxia","Impaired renal function disorder","Inflammatory bowel disease","Injury of head","Insomnia","Kidney disease","Lesion of brain","Low blood pressure","Metabolic acidosis","Metabolic alkalosis","Mood swings","Morbid obesity","Multiple organ failure","Myasthenia gravis","Myocardial dysfunction","Myocardial infarction","Myocardial infarction in recovery phase","Myocardial ischemia","Necrotizing enterocolitis in fetus OR newborn","Neoplasm of brain","Neutropenic disorder","Obsessive-compulsive disorder","Ocular hypertension","Oliguria","Operation on gastrointestinal tract","Panic disorder","Paralytic ileus","Partial atrioventricular block","Peptic reflux disease","Peptic ulcer","Peripheral edema","Poisoning by acetaminophen","Poisoning by phenobarbital","Porphyria","Pregnancy, function","Primary adrenocortical insufficiency","Procedure on urinary system","Pseudomembranous enterocolitis","Psychotic disorder","Pulmonary edema","Pulmonary emphysema","Pyloric obstruction","Retention of urine","Rhabdomyolysis","Seizure disorder","Sepsis syndrome","Severe Hypoxemia","Severe chronic ulcerative colitis","Severe dehydration","Shock","Sleep apnea","Smokes tobacco daily","Smoking cessation assistance","Spastic paralysis","Substance abuse","Suicidal thoughts","Tachyarrhythmia","Theophylline Toxicity","Third trimester pregnancy","Thrombocytopenic disorder","Toxic megacolon","Traumatic injury","Ulcerative colitis","Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant","Urethral stricture","Urinary tract obstruction","Ventricular 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Found in hundreds of cold/flu products. Available generically.","brandName":"Mucinex","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Vagal gastric reflex → increased respiratory secretions","novelty":"","modality":"Small molecule","drugClass":"Expectorant [EPC]","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:10:39.740121+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic (multiple manufacturers)","competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"guaifenesin","indications":{"approved":[{"name":"Allergic rhinitis","diseaseId":"allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Common 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