{"active_ingredient":["Active Ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema"],"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. if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions Take only as directed (see overdose warning) Do not take more than 4 doses in 24 hours. adults and children 12 years and over 2 softgels with water every 4 hours children 4 to under 12 years consult a doctor children under 4 years do not use"],"dosage_and_administration_table":["<table width=\"75%\"><colgroup><col align=\"left\" valign=\"top\" width=\"50%\"/><col align=\"left\" valign=\"top\" width=\"50%\"/></colgroup><tbody><tr><td styleCode=\"Rrule Botrule\">adults and children 12 years and over</td><td styleCode=\"Botrule\">2 softgels with water every 4 hours</td></tr><tr><td styleCode=\"Rrule Botrule\">children 4 to under 12 years</td><td styleCode=\"Botrule\">consult a doctor</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children under 4 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20251223","id":"46995a36-4233-ddce-e063-6294a90a1b8e","inactive_ingredient":["Inactive ingredients FD&C Red # 40, FD&C Yellow # 6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White ink."],"indications_and_usage":["Uses Temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Daytime Cold and Flu"],"generic_name":["ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd"],"package_ndc":["53345-056-01"],"product_ndc":["53345-056"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1867684"],"spl_id":["46995a36-4233-ddce-e063-6294a90a1b8e"],"spl_set_id":["46996bbf-948c-0aba-e063-6394a90a09e3"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","ACETAMINOPHEN"],"unii":["9D2RTI9KYH","362O9ITL9D"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Daytime Cold and Flu Capsules (PE free) Each softgel contains: Acetaminophen 325mg/ Dextromethorphan HBr 10mg NDC 53345-056-01 Caution: for further manufacturing, processing or repackaing Daytime Cold and Flu Capsules (PE free)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain Reliever/Fever Reducer Cough Suppressant"],"questions":["QUESTIONS OR COMMENTS? Call toll free: 1-855-215-8180"],"recent_major_changes":[""],"set_id":"46996bbf-948c-0aba-e063-6394a90a09e3","spl_product_data_elements":["Daytime Cold and Flu Acetaminophen and Dextromethorphan hydrobromide GLYCERIN GELATIN TYPE B BOVINE (150 BLOOM) POLYETHYLENE GLYCOL 400 WATER SORBITOL POVIDONE K12 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN SORBITAN ACETAMINOPHEN ACETAMINOPHEN PROPYLENE GLYCOL FD&C RED NO. 40 FD&C YELLOW NO. 6 Clear oblong P41"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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."],"storage_and_handling":["Other information Store at 15° - 30 °C (59°- 86 °F) Read all product information before using. Tamper evident: Do not use if carton is open or blister unit is broken."],"version":"1","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema When using this product do not exceed recommended dose. Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. 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 do not exceed recommended dose."]}