{"active_ingredient":["Active Ingredients (in each capsule) Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg Dextromethorphan Hydrobromide 10 mg Phenylepherine Hydrochloride 5 mg"],"ask_doctor":["Ask a doctor before use if you have ▪ liver disease ▪ a breathing problem such as emphysema or chronic bronchitis ▪ glaucoma ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficulty in urination due enlargement of the prostate gland."],"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 allergic to acetaminophen or any of the inactive ingredients in this product •in excess of recommended dosage ▪ 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 ▪ for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor ▪if you are taking sedatives or tranquilizers, without first consulting your doctor."],"dosage_and_administration":["Directions ▪ do not take more than directed (see overdose warning) ▪ do not use for more than 10 days unless directed by a doctor ▪ Adults and children 12 years of age and over ▪ take 2 capsule every 4 hours. ▪ do not take more than 12 capsules in 24 hours ▪ Children under 12 years of age ▪ do not use this adult product in children under 12 years of age; this will provide more than recommended dose (overdoes) and may cause liver damage."],"effective_time":"20200120","id":"9c9504a4-c6cb-362b-e053-2a95a90a5715","inactive_ingredient":["Inactive Ingredients DC red no. 33, FDC blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, water"],"indications_and_usage":["Uses temporarily relieves: ▪ minor aches and pains ▪ headache ▪ temporarily reduces fever ▪ runny nose ▪ sneezing ▪ itching of the nose or throat ▪ itchy, watery eyes due to hay fever or other upper respiratory allergies ▪ nasal congestion ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants"],"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 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":{},"package_label_principal_display_panel":["Package Label image description"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Antihistamine Antitussive (cough suppressant) Nasal decongestant"],"set_id":"0f93eac7-c9aa-4167-acfd-de5132e24047","spl_product_data_elements":["Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 600 POLYETHYLENE GLYCOL 1000 POVIDONE PROPYLENE GLYCOL WATER ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Sky Blue Soft liquid filled capsule Xtra"],"spl_unclassified_section":["Other Information Store at room temperature in a dry place"],"stop_use":["Stop use and ask a doctor if ▪ pain, nasal congestion or cough gets worse or lasts 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. ▪ nervousness, dizziness, or sleeplessness occur."],"version":"7","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 12 capsules in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks every day while using this product Do not exceed recommended dosage"],"when_using":["When using this product ▪ excitability may occur, especially in children ▪ may cause drowsiness ▪ alcohol, sedatives and tranquilizers may increase drowsiness effect ▪ use caution when driving a motor vehicle or operating machinery ▪ avoid alcoholic beverages"]}