{"active_ingredient":["Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if the user has liver disease heart disease thyroid disease diabetes high blood pressure a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin."],"do_not_use":["Do not use 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"dosage_and_administration":["Directions do not take more than directed (see overdose warning) do not exceed 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL=milliliter age dose adults and children 12 years and over 30 mL every 4 hours children 6 to 11 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing"],"dosage_and_administration_table":["
age dose
adults and children 12 years and over30 mL every 4 hours
children 6 to 11 years 15 mL every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not use
"],"effective_time":"20201201","id":"58cc3e36-c26c-49ed-b0bc-344ca2926ac4","inactive_ingredient":["Inactive ingredients citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum"],"indications_and_usage":["Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{},"other_safety_information":["Other information each 15 mL contains : sodium 12 mg store between 20-25ºC (68-77ºF) do not refrigerate"],"package_label_principal_display_panel":["Principal Display Panel *Compare to active ingredients in Vicks® DayQuil® Cold Preparation Acetaminophen Pain reliever/fever reducer Dextromethorphan hBr Cough suppressant Phenylephrine HCl Nasal decongestant For cough and sinus relief For ages 6 and over FL OZ (mL) TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company. Distributed by: New Genesis/Monticello Drug LLC Jacksonville, FL 32207","Package Label Monticello Cold Preparation Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or comments? Call us at 904-647-7825 or online at www.newgenesismonticellodrug.com"],"set_id":"667abca0-4235-492b-afcd-0c9d59ee7a01","spl_product_data_elements":["Cold Preparation For Cough and Sinus Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM TRISODIUM CITRATE DIHYDRATE SODIUM BENZOATE SODIUM CHLORIDE SORBITOL SUCRALOSE XANTHAN GUM"],"stop_use":["Stop use and ask a doctor if redness or swelling is present new symptoms occur nervousness, dizziness or sleeplessness occurs fever gets worse or lasts more than 3 days pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) cough comes back or occurs, with rash or headache that lasts. These could be signs of a serious condition."],"version":"6","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses (180 mL) in 24 hours for adults more than 5 doses ( 75 mL) in 24 hours for children 6-12 years old with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product Allery 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. Do not use 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if the user has liver disease heart disease thyroid disease diabetes high blood pressure a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage . Stop use and ask a doctor if redness or swelling is present new symptoms occur nervousness, dizziness or sleeplessness occurs fever gets worse or lasts more than 3 days pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) cough comes back or occurs, with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product, do not exceed recommended dosage ."]}