{"active_ingredient":["Active ingredients (in each tablet) Acetaminophen 325 mg Chlorpheniramine maleate 4 mg Phenylepherine HCl 10 mg"],"ask_doctor":["Ask adoctor before use if you have ■ liver disease ■ heart disease ■ glaucoma ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you ■ are taking the blood thinning drug warfarin ■ are taking sedatives or tranquilizers"],"do_not_use":["Do not use ■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ if you are taking a 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 contasins an MAOI, ask a doctor or pharmacist before taking this product. ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"dosage_and_administration":["Directions ■ Do not use more than directed (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age."],"effective_time":"20241024","id":"24b211e4-a9aa-47a2-e063-6394a90aa4d3","inactive_ingredient":["Inactive Ingredients Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive"],"indications_and_usage":["Uses temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children 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) 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":["Cold Medicine XL3 FORTE"],"generic_name":["ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Selder, S.A. de C.V."],"package_ndc":["63654-601-04","63654-601-50","63654-601-02","63654-601-20","63654-601-01","63654-601-10"],"product_ndc":["63654-601"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1193293"],"spl_id":["24b211e4-a9aa-47a2-e063-6394a90aa4d3"],"spl_set_id":["51dd467b-aae8-41fa-e054-00144ff8d46c"],"substance_name":["ACETAMINOPHEN","CHLORPHENIRAMINE MALEATE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","V1Q0O9OJ9Z","04JA59TNSJ"]},"package_label_principal_display_panel":["Package Label Package Label"],"purpose":["Purposes Pain reliever/fever reducer Antihistamine Nasal decongestant"],"questions":["Questions and Comments? You may report side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST"],"set_id":"51dd467b-aae8-41fa-e054-00144ff8d46c","spl_product_data_elements":["Cold Medicine XL3 FORTE Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride LACTOSE MONOHYDRATE STEARIC ACID POVIDONE HYPROMELLOSES TITANIUM DIOXIDE FD&C YELLOW NO. 5 ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WATER ALCOHOL TRIACETIN light yellow Tablet XL3;FORTE"],"spl_unclassified_section":["Other Information ■ store at room temperature 59-86F (15-30C) ■ do not use if package is torn or damaged"],"stop_use":["Stop use and ask a doctor if ■ redness or swelling is present ■ new symptoms occur ■ you get nervous, dizzy, or sleepless ■ pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days"],"version":"7","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 6 tablets 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 Alergy 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"],"when_using":["When using this product ■ do not use more than directed ■ excitability may occur, especially in children ■ may cause drowsiness ■ alcohol, sedatives and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery"]}