{"active_ingredient":["Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant"],"active_ingredient_table":["<table width=\"60%\"><col width=\"32%\"/><col width=\"29%\"/><thead><tr><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each caplet)</content></content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Acetaminophen 325 mg</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Pain reliever/fever reducer</paragraph></td></tr><tr><td valign=\"top\"><paragraph>Dextromethorphan HBr 10 mg</paragraph></td><td valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin 200 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis 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 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. If you have ever had an allergic reaction to this product r any of its ingredients In children under 12 years of age"],"dosage_and_administration":["Directions do not use more than directed. adults & children 12 years & over Take 2 caplets every 4 hours (do not take more than 12 caplets in 24 hours) children under 12 years of age 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=\"top\"><paragraph>adults &amp; children 12 years &amp; over</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Take 2 caplets every 4 hours (do not take more than 12 caplets in 24 hours)</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>children under 12 years of age</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20251223","id":"3dbd264d-5108-4b29-8881-728cea879dd7","inactive_ingredient":["Inactive ingredients Crospovidone, flavor, Hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, stearic acid, sucralose."],"indications_and_usage":["Uses temporarily relieves common cold and flu symptoms: cough sore throat headache minor aches and pains fever helps loosen phlegm (mucus) and thin bronchial secretions to get rid the bronchial passageways of bothersome mucus and make coughs more productive"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["KRAMER LABORATORIES"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["55505-230-24"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["55505-230"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2684921"],"spl_id":["3dbd264d-5108-4b29-8881-728cea879dd7"],"spl_set_id":["920bde5f-4079-45de-aa59-24b00e50cb56"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["362O9ITL9D","9D2RTI9KYH","495W7451VQ"],"upc":["0053076000085"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES NDC 55505-230-24 Safetussin® MAX STRENGTH MULTI-SYMPTOM Cough, Cold & Flu Acetaminophen / Pain Reliever Dextromethorphan HBr / Cough Suppressant Guaifenesin / Expectorant Safe for adults with High Blood Pressure Diabetes Relieves Headache Fever Sore Throat Body Aches & Pains Chest Congestion Cough Safetussin® contains: No decongestants No Sugar No Alcohol No sorbitol No fructose No gluten No dyes SUGAR & DECONGESTANT FREE 24 Caplets Always read and follow label directions. Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions. ©2024 Kramer Laboratories, Inc. Bridgewater, NJ 08807 SAFETUSSIN MS Cough Cold Flu 24 Caplets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant"],"purpose_table":["<table width=\"60%\"><col width=\"32%\"/><col width=\"29%\"/><thead><tr><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each caplet)</content></content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Acetaminophen 325 mg</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Pain reliever/fever reducer</paragraph></td></tr><tr><td valign=\"top\"><paragraph>Dextromethorphan HBr 10 mg</paragraph></td><td valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin 200 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"questions":["Questions or comments 1-866-467-2748"],"set_id":"920bde5f-4079-45de-aa59-24b00e50cb56","spl_product_data_elements":["SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin CROSPOVIDONE (120 .MU.M) HYPROMELLOSE 2208 (100 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE STEARIC ACID SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN Caplet"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 store at 15°-30°C (59° - 86°F). Keep this carton for future reference on full labeling."],"version":"2","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4000mg of acetaminophen in 24 hours, which is the maximum daily amount for this product in 24 hours taken 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. If you have ever had an allergic reaction to this product r any of its ingredients In children under 12 years of age Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product Do not use more than as directed Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children."],"when_using":["When using this product Do not use more than as directed"]}