{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg","Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 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, or emphysema","Ask a doctor before use if you have liver disease 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 4 doses 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 4 doses per 24 hours adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["
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
","
adults & children 12 yrs & over
2 softgels with water every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
"],"effective_time":"20250210","id":"2dc46c8a-7915-d95d-e063-6394a90aafa9","inactive_ingredient":["Inactive ingredients FD&C red#40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.","Inactive ingredients D&C yellow #10, 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 cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever","Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing"],"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 (1-800-222-1222) right away. Quick medical attention is critical for adults & 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 (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":["Daytime Nighttime Cold and Flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS"],"is_original_packager":[true],"manufacturer_name":["TIME CAP LABORATORIES INC."],"package_ndc":["49483-695-48"],"product_ndc":["49483-695"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997","1094549","2634564"],"spl_id":["2dc46c8a-7915-d95d-e063-6394a90aafa9"],"spl_set_id":["fd81dd4b-9617-f4c1-e053-6394a90a5e72"]},"other_safety_information":["Other information store at room temperature","Other information store at room temperature"],"package_label_principal_display_panel":["Timely_49483-695-48_IFC"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use.","If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/ Fever reducer Cough suppressant Nasal decongestant","Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine"],"questions":["Questions or comments? Call 1-877-290-4008","Questions or comments? Call 1-877-290-4008"],"set_id":"fd81dd4b-9617-f4c1-e053-6394a90a5e72","spl_product_data_elements":["Daytime Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI, Doxylamine Succinate 325, 10/15, 5, 6.25 mg softgels Daytime Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI 325, 10, 5 mg softgels SHELLAC ACETAMINOPHEN ACETAMINOPHEN FD&C RED NO. 40 GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 GLYCERIN POVIDONE TITANIUM DIOXIDE PROPYLENE GLYCOL WATER SORBITOL SOLUTION DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN SORBITAN 70 Oblong shaped Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate 325, 15, 6.25 mg softgels SHELLAC ACETAMINOPHEN ACETAMINOPHEN FD&C BLUE NO. 1 GELATIN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TITANIUM DIOXIDE WATER SORBITOL SOLUTION DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PROPYLENE GLYCOL SORBITAN 71 Oblong shaped"],"spl_unclassified_section":["Daytime Cold & Flu Drug Facts","Nighttime Cold & Flu Drug Facts"],"stop_use":["Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough get worse or last 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 pain 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":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hrs, 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 4 doses in 24 hrs, 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 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, & tranquilizers may increase drowsiness"]}