{"active_ingredient":["Active ingredients (in each packet) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 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 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 • do not use more than directed • take every 4 hours, while symptoms persist. Do not take more than 5 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":["
Age
Dose
adults and children 12 years of age and over
one packet
children under 12 years of age
do not use
"],"effective_time":"20260908","id":"c92ce24f-da56-4e02-81fa-3e34cfb6ba4b","inactive_ingredient":["Inactive ingredients citric acid, FD& C Blue No. 1, FD&C Red No. 40, flavor, maltodextrin, potassium chloride, silica, sucralose, sucrose."],"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 (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":["severe cold and cough daytime"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["RARITAN PHARMACEUTICALS INC"],"package_ndc":["68163-540-06"],"product_ndc":["68163-540"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1659967"],"spl_id":["c92ce24f-da56-4e02-81fa-3e34cfb6ba4b"],"spl_set_id":["3ce8508e-7d9d-4413-858a-8f952e760c01"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"],"upc":["0368163540062"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC# 68163-540-06 Compare to the active ingredients in Theraflu® Daytime Severe Cold & Cough* Day Time Severe Cold & Cough Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant Phenylephrine HCl Nasal Decongestant • Aspartame free • Sodium free Relieves • Body Ache • Cough • Fever • Headache • Nasal Congestion • Sore Throat Pain 6 PACKETS BERRY FLAVOR Infused With Menthol & Green Tea Flavor TAMPER EVIDENT: DO NOT USE INNER SEALED PACKET IF TORN 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® Daytime Severe Cold & Cough. DRx Choice Severe Cold & Cough Berry Flavor"],"package_label_principal_display_panel_table":["
TAMPER EVIDENT: DO NOT USE INNER SEALED PACKET IF TORN
"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"3ce8508e-7d9d-4413-858a-8f952e760c01","spl_product_data_elements":["severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN POTASSIUM CHLORIDE SILICON DIOXIDE SUCRALOSE SUCROSE mixture of white to light to dark red particles"],"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 ▪ pain, cough or nasal congestion gets worse or lasts more than 7 days ▪ cough comes back or occurs with 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 product from heat and moisture."],"version":"8","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 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 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 ▪ pain, cough or nasal congestion gets worse or lasts more than 7 days ▪ 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. In case of overdose, get medical help or contact a Poison Control Center right away (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"]}