{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg","Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 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 a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.","Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers 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.","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 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use","Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults &amp; children 12 yrs &amp; over</td><td>2 softgels with water every 4 hrs</td></tr><tr><td>children 4 to under 12 yrs</td><td>ask a doctor</td></tr><tr><td>children under 4 yrs</td><td>do not use</td></tr></tbody></table>","<table border=\"0\" width=\"100%\"><tbody><tr><td>adults &amp; children 12 yrs &amp; over</td><td>2 softgels with water every 4 hrs</td></tr><tr><td>children 4 to under 12 yrs</td><td>ask a doctor</td></tr><tr><td>children under 4 yrs</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20260316","id":"4d1d8a10-476d-1352-e063-6294a90a1279","inactive_ingredient":["Inactive ingredients FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide","Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide"],"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 passageways of bothersome mucus and make coughs more productive.","Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage"],"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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.","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). 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":["Daytime Nighttime Severe Cold and Flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["CVS HEALTH CORP"],"package_ndc":["51316-527-24","51316-527-48"],"product_ndc":["51316-527"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1297288","1656815","2634364"],"spl_id":["4d1d8a10-476d-1352-e063-6294a90a1279"],"spl_set_id":["23e2d2dc-12d4-294d-e063-6394a90a9523"]},"other_safety_information":["Other information do not exceed 25°C","Other information do not exceed 25°C"],"package_label_principal_display_panel":["627T 24ct 627T 48ct CVS 627T 24ct CVS 627T 48ct"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use.","If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant","Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant"],"questions":["Questions or comments? Call 1-877-290-4008","Questions or comments? Call 1-877-290-4008"],"set_id":"23e2d2dc-12d4-294d-e063-6394a90a9523","spl_product_data_elements":["Daytime Nighttime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Doxylamine Succinate, Phenylephrine HCl Daytime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl PROPYLENE GLYCOL FD&C BLUE NO. 1 SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED SHELLAC WATER FD&C RED NO. 40 POVIDONE TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GUAIFENESIN GUAIFENESIN GLYCERIN 73 Nighttime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl FD&C BLUE NO. 1 GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN SHELLAC DOXYLAMINE SUCCINATE DOXYLAMINE TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PROPYLENE GLYCOL WATER GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE ACETAMINOPHEN ACETAMINOPHEN SORBITOL 72"],"spl_unclassified_section":["Daytime Severe Cold and Flu - Drug Facts","Nighttime Severe Cold and Flu - Drug Facts"],"stop_use":["Stop use and ask a doctor if you get nervous, dizzy or sleepless 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.","Stop use and ask a doctor if you get nervous, dizzy or sleepless 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."],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels in 24 hours, 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.","Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels in 24 hours, 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.","When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness"]}