{"active_ingredient":["Active ingredients (in each 10 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg"],"ask_doctor":["Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are 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."],"dosage_and_administration":["Directions take only as directed do not exceed 4 doses per 24 hrs do not give more than directed (see liver warning) follow the instruction given on this carton for your eash use mL=mililiter Age (years) Dose (Sachet) Adults & Children 12 yrs & Over 2 sachets (20 mL*) every 4 hrs Children 6 to under 12 yrs 1 sachet (10 mL*) every 4 hrs Children 4 to under 6 yrs ask a doctor Children under 4 yrs do not use"],"dosage_and_administration_table":["<table cellspacing=\"2\" cellpadding=\"1\" border=\"1\"><tbody><tr><td><content styleCode=\"bold\">Age (years)</content></td><td><content styleCode=\"bold\">Dose (Sachet)</content></td></tr><tr><td>Adults &amp; Children 12 yrs &amp; Over</td><td>2 sachets (20 mL*) every 4 hrs</td></tr><tr><td>Children 6 to under 12 yrs</td><td>1 sachet (10 mL*) every 4 hrs</td></tr><tr><td>Children 4 to under 6 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":"20260515","id":"51d52ce4-98c5-2b9b-e063-6294a90ade44","inactive_ingredient":["Inactive Ingredients citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum, edetate sodium."],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever"],"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 as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER"],"generic_name":["ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS"],"is_original_packager":[true],"manufacturer_name":["MEDWISE LIFESCIENCES INC."],"package_ndc":["87078-331-01","87078-331-16"],"product_ndc":["87078-331"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1919076"],"spl_id":["51d52ce4-98c5-2b9b-e063-6294a90ade44"],"spl_set_id":["51d52ce4-98c4-2b9b-e063-6294a90ade44"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","ACETAMINOPHEN"],"unii":["9D2RTI9KYH","362O9ITL9D"],"upc":["0850078212191"]},"other_safety_information":["Other Information store between 20 - 25° C (68-77° F) Do not use if carton or sachet is torn, broken or punctured."],"package_label_principal_display_panel":["NDC 87078-331-16"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant"],"questions":["Question or Comments? Call 1-516-675-8915"],"recent_major_changes":["add estric mark on 10 mL"],"set_id":"51d52ce4-98c4-2b9b-e063-6294a90ade44","spl_product_data_elements":["ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER Acetaminophen 325 mg and Dextromethorphan HBr 10 mg Oral Liquid Day Time Kids SODIUM CITRATE XANTHAN GUM SODIUM BENZOATE ANHYDROUS CITRIC ACID EDETATE DISODIUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN SODIUM SACCHARIN MENTHOL WATER ACETAMINOPHEN ACETAMINOPHEN SUCRALOSE GLYCERIN SORBITOL SOLUTION 70% FD&C BLUE NO. 1 PROPYLENE GLYCOL FD&C RED NO. 40"],"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."],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (20 mL each) in 24 hrs, which is the maximum daily amount for this product child takes more than 4 doses (10 mL each) in 24 hrs, which is the maximum daily amount for this product taken with other drugs containing acetaminophen adult has 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."]}