{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg"],"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"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"> adults &amp; children 12 yrs &amp; over</td><td styleCode=\"Botrule Lrule Rrule Toprule\"> 2 softgels with water every 4 hrs</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"> children 4 to under 12 yrs</td><td styleCode=\"Botrule Lrule Rrule Toprule\"> ask a doctor</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"> children under 4 yrs</td><td styleCode=\"Botrule Lrule Rrule Toprule\"> do not use</td></tr></tbody></table>"],"effective_time":"20250922","id":"6e465e67-b986-4be5-9ee2-d29f21a5e5c8","inactive_ingredient":["Inactive ingredients D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, 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 • 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center 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":["RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Strive Pharmaceuticals Inc."],"package_ndc":["70692-837-84"],"product_ndc":["70692-837"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1297288"],"spl_id":["6e465e67-b986-4be5-9ee2-d29f21a5e5c8"],"spl_set_id":["9f050fb0-6100-4b14-b82f-1d5fcbf16540"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2","04JA59TNSJ"],"upc":["0370692001235"]},"package_label_principal_display_panel":["Packaging NIGHTTIME SEVERE COLD AND FLU"],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant"],"questions":["Questions or comments? 1-888-577-8033 Monday - Friday 8am - 4pm EST"],"set_id":"9f050fb0-6100-4b14-b82f-1d5fcbf16540","spl_product_data_elements":["RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SORBITOL SORBITAN TITANIUM DIOXIDE A07"],"spl_unclassified_section":["Drug Facts","Compare to the active ingredients in Vicks ® NyQuil™ Severe Cold & Flu LiquiCaps™* MAX STRENGTH TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks ® NyQuil™ LiquiCaps™. Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 PRODUCT OF INDIA"],"storage_and_handling":["Other information • store at controlled room temperature 20–25°C (68–77°F) • protect from light, heat, and moisture"],"version":"1","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. 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 • 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 a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin 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 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. 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}