{"active_ingredient":["Active ingredients (in each 20 mL) Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg"],"ask_doctor":["Ask a doctor before use if you have ▪ liver disease ▪ cough that occurs with too much phlegm (mucus) ▪ a breathing problem or chronic cough that lasts or 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 ▪ taking any other pain reliever/fever reducer"],"do_not_use":["Do not use ▪ 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. ▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"dosage_and_administration":["Directions ▪ do not take more than 6 doses in any 24-hour period ▪ do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ mL = milliliter ▪ this adult product is not intended for use in children under 12 years of age Age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>Age</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>dose</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>adults and children 12 years and over</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>20 mL every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>children under 12 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20260909","id":"e236c8b2-9c58-4066-b509-001114e7000a","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, FD&C red No 40, glycerin, menthol, flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum."],"indications_and_usage":["Uses ▪ temporarily relieves these symptoms occurring with a cold or flu: ▪ cough due to minor throat and bronchial irritation ▪ minor aches and pains ▪ sore throat ▪ headache ▪ temporarily reduces 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 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":["DRx Choice maximum strength Severe Cough plus sore throat"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["RARITAN PHARMACEUTICALS"],"package_ndc":["68163-749-08"],"product_ndc":["68163-749"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1919076"],"spl_id":["e236c8b2-9c58-4066-b509-001114e7000a"],"spl_set_id":["a096cb76-0d1c-4ca8-854a-5199da0bc8f7"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["362O9ITL9D","9D2RTI9KYH"]},"package_label_principal_display_panel":["Principal Display Panel Compare to active ingredients in Robitussin ® Maximum Strength Severe Cough + Sore Throat CF MAX* NDC 68163-749-08 DRx Choice® maximum strength SEVERE cough + sore throat Acetaminophen (Pain reliever / Fever reducer) Dextromethorphan HBr (Cough Suppressant) Relieves: • Cough • Sore throat pain For Ages 12 Years & over • No added Sugar • No added Alcohol Strong Cooling Liquid 8 FL OZ (237 mL) *This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Robitussin® Maximum Strength Severe Cough + Sore Throat CF MAX. Maximum Strength claim based on maximum levels of active ingredients per dose. IMPORTANT: Keep this carton for future reference on full labeling. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick NJ, 08816 DRx Choice Max Strength SEVERE cough + sore throat"],"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\">IMPORTANT: Keep this carton for future reference on full labeling.</content></paragraph></td></tr></tbody></table>"],"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? 1-866-467-2748"],"set_id":"a096cb76-0d1c-4ca8-854a-5199da0bc8f7","spl_product_data_elements":["DRx Choice maximum strength Severe Cough plus sore throat Acetaminophen, Dextromethorphan HBr ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM"],"stop_use":["Stop use and ask a doctor if ▪ pain 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."],"storage_and_handling":["Other information ▪ each 20 mL contains: sodium 10 mg ▪ store at room temperature Do not refrigerate."],"version":"4","warnings":["Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 6 doses in any 24 hours period, which is the maximum daily amount ▪ 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."],"when_using":["When using this product do not use more than directed."]}