{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"],"dosage_and_administration":["Directions • take only as directed - see overdose warning • do not exceed 4 doses per 24 hrs adults and children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["<table width=\"60%\"><tbody><tr><td styleCode=\"Botrule Rrule\"> adults and children 12 yrs &amp; over</td><td styleCode=\"Botrule\" align=\"right\">2 softgels with water every 4 hrs</td></tr><tr><td styleCode=\"Botrule Rrule\"> children 4 to under 12</td><td styleCode=\"Botrule\" align=\"right\">ask a doctor </td></tr><tr><td styleCode=\"Rrule\"> children under 4 yrs</td><td align=\"right\">do not use </td></tr></tbody></table>"],"effective_time":"20241211","id":"571f5919-82e2-4532-9e22-2b83ec698037","inactive_ingredient":["Inactive ingredients edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution"],"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"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Packaging Strive-807"],"purpose":["Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or comments 1-888-577-8033 Monday - Friday 8am - 4pm EST"],"set_id":"07f70981-765f-4d3c-9106-a89ab0ac195f","spl_product_data_elements":["DayTime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN 807"],"spl_unclassified_section":["Drug Facts","Compare to the active ingredients of Vicks ® DayQuil™ Cold & Flu Relief LiquiCaps™* RIGHT REMEDIES READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION *This product is not manufactured or distributed by Procter & Gamble Company, owner of the registered trademarks Vicks ® and DayQuil™. Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 Product of UAE Packaged and Quality Assured in the USA DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING REV.00-072022"],"storage_and_handling":["Other information • store at room temperature between 20-25°C (68-77°F)"],"version":"3","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 daily 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, occurs with or is 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. 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 as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."]}