{"active_ingredient":["Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 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 30 mL dose cup)</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 650 mg</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Pain reliever/fever reducer</paragraph></td></tr><tr><td valign=\"top\"><paragraph>Dextromethorphan HBr 20 mg</paragraph></td><td valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin 400 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 take more than directed ▪ do not take more than 6 doses in any 24-hours period ▪ measure only with dosing cup provided ▪ dose as follows or as directed by a doctor adults & children 12 years & older 30 mL per dose every 4 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; older</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>30 mL per dose every 4 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":"df0f0e0c-323c-49e5-8432-c09cf950b20d","inactive_ingredient":["Inactive ingredients Anhydrous citric acid, edetate disodium, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum."],"indications_and_usage":["Uses temporarily relieves common cold/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 High Blood Pressure and diabetes 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":["55505-217-36"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["55505-217"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1042695"],"spl_id":["df0f0e0c-323c-49e5-8432-c09cf950b20d"],"spl_set_id":["279e309c-040d-4001-808d-b7d986a9a1d8"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["362O9ITL9D","9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES NDC 55505-217-36 Safetussin® MAX STRENGTH MULTI-SYMPTOM Cough, Cold & Flu Acetaminophen / Pain Reliever 650 mg Dextromethorphan HBr / Cough Suppressant 20 mg Guaifenesin / Expectorant 400 mg 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 Pharmacist Recommended Brand 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. 8 FL OZ (237 mL) Questions? Comments? Call 1-800-824-4894 ©2023 Kramer Laboratories, Inc. Bridgewater, NJ 08807 Safetussin High Blood Pressure Multi symtoms relief 8 FL OZ (237 ml)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 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 30 mL dose cup)</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 650 mg</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Pain reliever/fever reducer</paragraph></td></tr><tr><td valign=\"top\"><paragraph>Dextromethorphan HBr 20 mg</paragraph></td><td valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin 400 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"set_id":"279e309c-040d-4001-808d-b7d986a9a1d8","spl_product_data_elements":["Safetussin High Blood Pressure and diabetes Cough, Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERIN MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE XANTHAN GUM"],"spl_unclassified_section":["Drug Facts","Distributed by"],"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 • each 30 mL contains: sodium19 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 24 hours, which is the maximum daily amount for this product ▪ 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"]}