{"active_ingredient":["Active ingredients (in each packet) Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 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 an enlarged prostate gland ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic 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 ▪ in a child under 12 years of age ▪ if you are allergic to acetaminophen ▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 a MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions ▪ do not use more than directed ▪ take every 4 hours, while symptoms persist. do not take more than 6 packets in 24 hours unless directed by a doctor Age Dose Adults and children 12 years of age and over One packet Children under 12 years of age Do not use ▪ dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. ▪ if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat."],"dosage_and_administration_table":["<table width=\"90.22%\"><col width=\"49%\"/><col width=\"42%\"/><tbody><tr><td align=\"center\" styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph> Age</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Dose</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>Adults and children 12 years of age and over</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>One packet</paragraph></td></tr><tr><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>Children under 12 years of age</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20260908","id":"cc570224-677d-4eb0-b629-0da2d7d518ec","inactive_ingredient":["Inactive ingredients citric acid, caramel, flavors, maltodextrin ,potassium chloride, silica, sucralose, sucrose, Questions or Comments 1-866-467-2748"],"indications_and_usage":["Uses ▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ nasal and sinus congestion ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces 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 right away at 1-800-222-1222. Prompt 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":["Multi Symptom Severe Cold"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["RARITAN PHARMACEUTICALS INC"],"package_ndc":["68163-547-06"],"product_ndc":["68163-547"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1189316"],"spl_id":["cc570224-677d-4eb0-b629-0da2d7d518ec"],"spl_set_id":["d9606c9a-31b1-4121-9870-809a05f5b68a"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"]},"package_label_principal_display_panel":["Principal Display DRx Choice® NDC# 68163-547-06 Compare to the active ingredients in Theraflu ® Multi-Symptom Severe Cold* MULTI-SYMPTOM Severe Cold ACETAMINOPHEN - Pain Reliever/ Fever Reducer DEXTROMETHORPHAN HBr - Cough Suppressant PHENYLEPHRINE HCl - Nasal Decongestant • Aspartame Free • Dye free • Sodium free Relieves • Body ache • Cough • Fever • Headache • Nasal congestion • Sore throat pain Green Tea & Honey Lemon Flavors Infused with Menthol & Green Tea Flavors 6 PACKETS TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu ® Multi-Symptom Severe Cold. Multi Symptom Severe Cold Acetaminphen"],"package_label_principal_display_panel_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.</content></paragraph></td></tr></tbody></table>"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health care professional before use."],"purpose":["Purposes Pain reliever/Fever reducer Cough Suppressant Nasal Decongestant"],"questions":["Questions or Comments 1-866-467-2748"],"set_id":"d9606c9a-31b1-4121-9870-809a05f5b68a","spl_product_data_elements":["Multi Symptom Severe Cold ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID CARAMEL MALTODEXTRIN POTASSIUM CHLORIDE SILICON DIOXIDE SUCRALOSE SUCROSE Green Tea and Honey Lemon"],"stop_use":["Stop use and ask a doctor if ▪ nervousness, dizziness, or sleeplessness occurs ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ symptoms do not get better or worsen ▪ pain, cough or nasal congestion gets worse or lasts more than 7 days ▪ cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information ▪ each packet contains: potassium 6 mg ▪ store at room temperature. Protect from excessive heat and moisture."],"version":"9","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 4,000 mg of acetaminophen in 24 hours ▪ 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 ▪ in a child under 12 years of age ▪ if you are allergic to acetaminophen ▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 a 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 an enlarged prostate gland ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such 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 exceed recommended dosage Stop use and ask a doctor if ▪ nervousness, dizziness, or sleeplessness occurs ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ symptoms do not get better or worsen ▪ pain, cough or nasal congestion gets worse or lasts more than 7 days ▪ cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. 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 dosage"]}