{"active_ingredient":["Active ingredients (in each Softgel) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Guaifenesin USP 200 mg Phenylephrine HCl USP 5 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such 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."],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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."],"dosage_and_administration":["Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 years & over 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use"],"dosage_and_administration_table":["
adults & children 12 years & over2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use
"],"effective_time":"20260128","id":"47b5293b-c76d-4cd3-e063-6394a90a29b5","inactive_ingredient":["Inactive ingredients FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr"],"generic_name":["ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["Softgel Healthcare Pvt Ltd"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["35916-0166-1"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["35916-0166"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1656815"],"spl_id":["47b5293b-c76d-4cd3-e063-6394a90a29b5"],"spl_set_id":["24bc9ae6-8e8f-c0a0-e063-6394a90a407f"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","DEXTROMETHORPHAN HYDROBROMIDE","ACETAMINOPHEN","GUAIFENESIN"],"unii":["04JA59TNSJ","9D2RTI9KYH","362O9ITL9D","495W7451VQ"],"upc":["0335916016617"]},"other_safety_information":["Other information store at no greater than 25 ° C"],"package_label_principal_display_panel":["MAX STRENGTH NDC 35916-0166-1 Compared to the active ingredient in Vicks® DayQuil ™ severe COLD & FLU LiquiCaps™ Acetaminophen 325mg, Guaifenesin 200mg, Phenylephrine HCl 5mg And Dextromethorphan HBr 10mg Softgelatin Capsules Headache, Fever, Sore throat, Minor aches & Pains Chest congestion, Thins & loosen mucus Nasal congestion, Sinus Pressure cough 24 Softgels Day Time Severe Cold & Flu (Non-Drowsy) Day time Severe"],"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":"24bc9ae6-8e8f-c0a0-e063-6394a90a407f","spl_product_data_elements":["Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr WATER SORBITOL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL GLYCERIN POVIDONE ACETAMINOPHEN ACETAMINOPHEN FD&C RED NO. 40 GUAIFENESIN GUAIFENESIN FD&C YELLOW NO. 6 GELATIN oblong square Transparent"],"stop_use":["Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough get worse or last more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels in 24 hrs, which is the maximum daily amount for this product 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 If a skin reaction occurs, stop use and seek medical help right away 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 promptly."],"when_using":["When using this product do not use more than directed."]}