{"active_ingredient":["Active ingredients (in each chewable tablet) Acetaminophen 325 mg Dextromethorphan equivalent to 10 mg Dextromethorphan HBr"],"ask_doctor":["Ask a doctor before use if you have ▪ liver disease ▪ 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 ▪ do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist. Age Dose adults and children 12 years of age and over take 2 chewable tablets every 4 hours children under 12 years of age do not use"],"dosage_and_administration_table":["
AgeDose
adults and children 12 years of age and overtake 2 chewable tablets every 4 hours
children under 12 years of agedo not use
"],"effective_time":"20240619","id":"91dbb541-6a86-4803-a1fe-1bf61b457c34","inactive_ingredient":["Inactive ingredients calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk"],"indications_and_usage":["Uses ▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ sore throat pain ▪ headache ▪ 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. 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":["Theraflu Severe Cold Relief Soft Chews"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0067-0111-01","0067-0111-02"],"product_ndc":["0067-0111"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2685209"],"spl_id":["91dbb541-6a86-4803-a1fe-1bf61b457c34"],"spl_set_id":["91dbb541-6a86-4803-a1fe-1bf61b457c34"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["362O9ITL9D","9D2RTI9KYH"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NEW THERAFLU SEVERE COLD RELIEF SOFT CHEWS Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant FAST relief ANYWHERE cough / sore throat / headache / body aches / fever 20 CHEWABLE TABLETS Chew tablets completely before swallowing Apple Cinnamon Flavor Theraflu SCR Soft Chews Daytime 20ct"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/Fever reducer Cough suppressant"],"questions":["Questions or comments? call 1-855-328-5359"],"set_id":"91dbb541-6a86-4803-a1fe-1bf61b457c34","spl_product_data_elements":["Theraflu Severe Cold Relief Soft Chews Acetaminophen, Dextromethorphan HBr ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CALCIUM GLUCONATE MONOHYDRATE CARBOXYMETHYLCELLULOSE CALCIUM CARNAUBA WAX CORN SYRUP CROSPOVIDONE, UNSPECIFIED FD&C RED NO. 40 ALUMINUM OXIDE FD&C YELLOW NO. 6 GLYCERIN MANNITOL STARCH, CORN SODIUM GLUCONATE SORBITOL SORBITOL SOLUTION SUCRALOSE SUCROSE COW MILK T"],"spl_unclassified_section":["Other information ▪ each chewable tablet contains: potassium 10 mg, sodium 6 mg ▪ store at a controlled room temperature 20-25°C (68-77°F)","Generic Section Do Not Use if seal under bottle cap imprinted with \"SEALED for YOUR PROTECTION” is broken or missing. Distributed by: Haleon, Warren, NJ 07059 Trademarks are owned by or licensed to the Haleon group of companies. Pat. Info www.productpats.com ©2024 Haleon group of companies or its licensor. PARENTS: Learn about teen medicine abuse. www.StopMedicineAbuse.org 211433 56047666 Peel Here"],"stop_use":["Stop use and ask a doctor if ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ pain or cough 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."],"version":"1","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 ▪ 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 Stop use and ask a doctor if ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ pain or cough 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}