{
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-10",
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    {
      "spl_product_data_elements": [
        "CVS Mucus Relief DM and Overnight Cold and Flu Dextromethorphan HBr, Guaifenesin, Acetaminophen and Triprolidine HCl Maximum Strength Mucus Relief DM Dextromethorphan HBr and Guaifenesin ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 POTASSIUM CITRATE PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN Overnight Cold and Flu Acetaminophen, Dextromethorphan HBr and Triprolidine HCl ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients (in each 20 mL) Maximum Strength Mucus Relief DM Max Purposes Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Active ingredients (in each 20 mL) Purposes Nighttime Cold & Flu Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine"
      ],
      "active_ingredient_table": [
        "<table width=\"65%\"><col width=\"37%\"/><col width=\"29%\"/><thead><tr><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 20 mL)</content></content> <content styleCode=\"bold\">Maximum Strength Mucus Relief DM Max</content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></th></tr></thead><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Dextromethorphan HBr 20 mg</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td valign=\"top\"><paragraph>Guaifenesin 400 mg</paragraph></td><td valign=\"top\"><paragraph>Expectorant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"/><td styleCode=\"Botrule \" valign=\"top\"/></tr></tbody></table>",
        "<table width=\"65%\"><col width=\"36%\"/><col width=\"29%\"/><thead><tr><th align=\"left\" styleCode=\"Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 20 mL)</content></content></th><th align=\"left\" styleCode=\"Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></th></tr><tr><th align=\"left\" colspan=\"2\" styleCode=\"Botrule \" valign=\"top\"><content styleCode=\"bold\">Nighttime Cold &amp; Flu</content></th></tr></thead><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Acetaminophen 650 mg</content></paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Pain reliever/fever reducer</content></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>Triprolidine HCl 2.5 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Antihistamine</paragraph></td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients (in each 20 mL) Maximum Strength Mucus Relief DM Max Purposes Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Active ingredients (in each 20 mL) Purposes Nighttime Cold & Flu Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine"
      ],
      "purpose_table": [
        "<table width=\"65%\"><col width=\"37%\"/><col width=\"29%\"/><thead><tr><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 20 mL)</content></content> <content styleCode=\"bold\">Maximum Strength Mucus Relief DM Max</content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></th></tr></thead><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Dextromethorphan HBr 20 mg</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td valign=\"top\"><paragraph>Guaifenesin 400 mg</paragraph></td><td valign=\"top\"><paragraph>Expectorant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"/><td styleCode=\"Botrule \" valign=\"top\"/></tr></tbody></table>",
        "<table width=\"65%\"><col width=\"36%\"/><col width=\"29%\"/><thead><tr><th align=\"left\" styleCode=\"Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 20 mL)</content></content></th><th align=\"left\" styleCode=\"Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></th></tr><tr><th align=\"left\" colspan=\"2\" styleCode=\"Botrule \" valign=\"top\"><content styleCode=\"bold\">Nighttime Cold &amp; Flu</content></th></tr></thead><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Acetaminophen 650 mg</content></paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Pain reliever/fever reducer</content></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>Triprolidine HCl 2.5 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Antihistamine</paragraph></td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses MAXIMUM STRENGTH MUCUS RELIEF DM helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep",
        "Uses (Nighttime Cold and Flu) temporarily relieves these common cold and flu symptoms: cough minor aches and pains sore throat headache runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep"
      ],
      "warnings": [
        "Warnings 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. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more that directed Stop use and ask a doctor if cough lasts more than 7 days comes back or occurs with fever, rash or headache that lasts. These could be sings of a serious condition. If pregnancy 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 Centre right away at 1-800-222-1222",
        "Warnings Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take\\ more than 4000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product If pregnant or breast feeding Ask a health professional before use Keep Out of Reach of Children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centre right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs Directions do not take more than directed (see overdose warnings do not take more than 4 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and older: 20 ml in dosing cup provided every 4 hours children under 12 years of age: do not use Other Information each 20 mL contains: sodium 10 mg low sodium store at room temperature do not refrigerate"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more that directed Stop use and ask a doctor if cough lasts more than 7 days comes back or occurs with fever, rash or headache that lasts. These could be sings of a serious condition. If pregnancy 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 Centre right away at 1-800-222-1222"
      ],
      "when_using": [
        "When using this product do not use more that directed Stop use and ask a doctor if cough lasts more than 7 days comes back or occurs with fever, rash or headache that lasts. These could be sings of a serious condition. If pregnancy 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 Centre right away at 1-800-222-1222"
      ],
      "stop_use": [
        "Stop use and ask a doctor if cough lasts more than 7 days comes back or occurs with fever, rash or headache that lasts. These could be sings of a serious condition. If pregnancy 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 Centre right away at 1-800-222-1222"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnancy 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 Centre right away at 1-800-222-1222",
        "If pregnant or breast feeding Ask a health professional before use Keep Out of Reach of Children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centre right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs Directions do not take more than directed (see overdose warnings do not take more than 4 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and older: 20 ml in dosing cup provided every 4 hours children under 12 years of age: do not use Other Information each 20 mL contains: sodium 10 mg low sodium store at room temperature do not refrigerate"
      ],
      "keep_out_of_reach_of_children": [
        "Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison control Centre right away at 1-800-222-1222",
        "Keep Out of Reach of Children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centre right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs"
      ],
      "dosage_and_administration": [
        "Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years and older: 20 mL every 4 hours children under 12 years of age: Do not use",
        "Directions do not take more than directed (see overdose warnings do not take more than 4 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and older: 20 ml in dosing cup provided every 4 hours children under 12 years of age: do not use Other Information each 20 mL contains: sodium 10 mg low sodium store at room temperature do not refrigerate"
      ],
      "storage_and_handling": [
        "Other information each 20 mL contains: sodium 8 mg low sodium store at room temperature do not refrigerate dosing cup provided"
      ],
      "inactive_ingredient": [
        "Inactive ingredients (Maximum strength mucus relief DM) anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red No. 40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum",
        "Inactive ingredients (Overnight Cold & Flu) anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum"
      ],
      "other_safety_information": [
        "Other Information each 20 mL contains: sodium 10 mg low sodium store at room temperature do not refrigerate"
      ],
      "questions": [
        "Questions or comments? (1-866-467-2748)"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - Kit Carton VALUE PACK NDC 69842-696-12 Compare to the active ingredients Maximum Strength Mucinex® Fast Max® DM Max* Mucus Relief DM Dextromethorphan HBr • Cough Suppressant Guaifenesin • Expectorant MAXIMUM STRENGTH MULTI-SYMPTOM Controls Cough Relieves chest congestion Thins & loosens mucus 4 hour dosing For Ages 12+ *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast-Max® DM Max. Compare to Mucinex® Nightshift Cold & Flu Active Ingredients** Overnight Cold & Flu ACETAMINOPHEN • PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBR • COUGH SUPPRESSANT TRIPROLIDINE HCL • ANTIHISTAMINE Night Time Relief for Better Morning Maximum Strength per 4-hour dose Cough Fever Sore Throat Runny Nose Sneezing For Ages 12+ 2 – 6 FL OZ (180 mL) BOTTLES / TOTAL 12 FL OZ (360 mL) †† These product is not manufactured or distributed by Reckitt Benckister Health, distributor of Maximum Strength Mucinex® Fast Max© DM Max & Mucinex© Nightshift Cold & Flu. DO NOT TAKE ADULT DM MAXIMUM & NIGHTTIME COLD & FLU LIQUIDS AT THE SAME TIME. TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.; See bottle for full labeling Distributed By: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2020 CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-12431 CVS ® Quality Money Back Guarantee CVS Health ADULT DM MAXIMUM & NIGHTTIME COLD and FLU Value pack"
      ],
      "package_label_principal_display_panel_table": [
        "<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">DO NOT TAKE ADULT DM MAXIMUM &amp; NIGHTTIME COLD &amp; FLU LIQUIDS AT THE SAME TIME.</content></paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.;</content></paragraph></td></tr></tbody></table>"
      ],
      "set_id": "75520b77-d40b-4f43-b92a-7a3eba5b493f",
      "id": "458272a0-024b-43d1-e063-6394a90aeac4",
      "effective_time": "20251209",
      "version": "8",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "CVS Mucus Relief DM and Overnight Cold and Flu"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL"
        ],
        "manufacturer_name": [
          "CVS"
        ],
        "product_ndc": [
          "69842-696"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "1020138",
          "2173667",
          "2287760"
        ],
        "spl_id": [
          "458272a0-024b-43d1-e063-6394a90aeac4"
        ],
        "spl_set_id": [
          "75520b77-d40b-4f43-b92a-7a3eba5b493f"
        ],
        "package_ndc": [
          "69842-696-12"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}