{"active_ingredient":["Active ingredients Active ingredients (in each tablet) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Guaifenesin 200 mg Phenylephrine HCI 5 mg"],"ask_doctor":["Ask a doctor before use if you have Ask a doctor before use if you have ■ liver disease ■ heart disease ■ diabetes ■ thyroid disease ■ high blood pressure ■ trouble urinating due to an 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 Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin"],"do_not_use":["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 Directions adults and children 12 years and over ■ take 2 tablets with water every 6-8 hours as needed ■ do not take more than 8 tablets in 24 hours, or as directed by a doctor children under 12 years of age ask a doctor"],"dosage_and_administration_table":["
adults and children12 years and over■ take 2 tablets with water every 6-8 hours as needed■ do not take more than 8 tablets in 24 hours, or as directed by a doctor
children under12 years of ageask a doctor
"],"effective_time":"20220809","id":"e5d4520d-3baf-9916-e053-2995a90ae273","inactive_ingredient":["Inactive ingredients Inactive ingredients maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid *may contain"],"indications_and_usage":["Uses Uses ■ for the temporary relief of the following cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough ■ impulse to cough ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ■ temporarily reduces fever"],"keep_out_of_reach_of_children":["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. (1-800-222-1222) Prompt 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":["PDP/Package Cold Acetaminophen , Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SEVERE CONGESTION Non-Drowsy Relief of Cough, Im[pulse to Cough Nasal Congestion Sore Throat 50 PACKETS OF 2 TABLETS [barcode] 3 66715 97187 6 PDP Pouch"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or comments? Questions or comments? call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)"],"recent_major_changes":[""],"set_id":"e5d4520d-3bae-9916-e053-2995a90ae273","spl_product_data_elements":["Cold Severe Congestion Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride tablet PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SODIUM STARCH GLYCOLATE TYPE A CORN SILICON DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN MALTODEXTRIN STARCH, CORN STEARIC ACID GUAIFENESIN GUAIFENESIN CELLULOSE, MICROCRYSTALLINE POVIDONE, UNSPECIFIED white to off-white FR;12"],"spl_unclassified_section":["Drug Facts ​Drug Facts"],"stop_use":["Stop use and ask a doctor if 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 is accompanied by a fever, rash or persistent headache ■ nervousness, dizziness, or sleeplessness occur. These could be signs of a serious condition."],"storage_and_handling":["Other information Other information ■ store at room temperature 59-86˚ F (15-30˚ C)"],"version":"1","warnings":["Warnings Liver warning 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 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 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. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. 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. Ask a doctor before use if you have Ask a doctor before use if you have ■ liver disease ■ heart disease ■ diabetes ■ thyroid disease ■ high blood pressure ■ trouble urinating due to an 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 a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin When using this product When using this product ■ do not exceed recommended dosage Stop use and ask a doctor if 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 is accompanied by a fever, rash or persistent headache ■ nervousness, dizziness, or sleeplessness occur. These could be signs of a serious condition. If pregnant or breast-feeding If pregnant or breast-feeding , ask a health professional before use. 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. (1-800-222-1222) Prompt 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 When using this product ■ do not exceed recommended dosage"]}