{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 100 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have heart, liver, or thyroid disease high blood pressure diabetes glaucoma trouble urinating due to an enlarged prostate a breathing problem or a cough with too much phlegm (mucus) or a cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin you do not know if other drugs you are taking contain acetaminophen"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription) if you have ever had an allergic reaction to this product or any of its ingredients 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, or if you do not know if your prescription drug contains an MAOI"],"dosage_and_administration":["Directions Do not take more than directed Adults and children 12 years of age and over take 2 caplets every 6 to 8 hours while symptoms persist do not take more than 8 caplets in 24 hours unless directed by a doctor Children under 12 years of age: ask a doctor"],"effective_time":"20251224","id":"866ea7b4-cf9b-4001-a533-12b8f562e042","inactive_ingredient":["Inactive ingredients corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone,silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide"],"indications_and_usage":["Uses Temporarily relieves these cold and flu symptoms cough sore throat headache minor aches and pains nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and bronchial secretions to coughs more productive Temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M"],"brand_name":["CETAFEN COUGH and COLD"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,"],"is_original_packager":[true],"manufacturer_name":["HART Health"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["50332-0141-3","50332-0141-4","50332-0141-7"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["50332-0141"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1098435"],"spl_id":["866ea7b4-cf9b-4001-a533-12b8f562e042"],"spl_set_id":["44da0d8c-4a12-4122-99da-781e2809e1a8"],"substance_name":["GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE","ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","04JA59TNSJ","362O9ITL9D","9D2RTI9KYH"]},"other_safety_information":["Other information: caplets enclosed in a sealed packet do not use if packet is torn, cut or open store at 59° to 86°F (15°-30°C) avoid excessive heat and humidity"],"overdosage":["Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222"],"package_label_principal_display_panel":["CetafenCough.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"],"set_id":"44da0d8c-4a12-4122-99da-781e2809e1a8","spl_product_data_elements":["CETAFEN COUGH and COLD Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, , GUAIFENESIN GUAIFENESIN MICROCRYSTALLINE CELLULOSE TALC POLYVINYL ALCOHOL, UNSPECIFIED CROSPOVIDONE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 POLYETHYLENE GLYCOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN POVIDONE SILICON DIOXIDE MALTODEXTRIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN STARCH, CORN MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE STEARIC ACID 44;546 Caplet"],"stop_use":["Stop use and ask a doctor if an allergic reaction occurs, seek medical help right away redness or swelling is present you get nervous, dizzy, or sleepless new symptoms occur fever worsens or lasts more than 3 days pain, nasal congestion, or cough worsens or lasts more than 7 days cough comes back or occurs with a rash or headache that lasts These could be signs of a serious condition."],"version":"4","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor right away."]}