Label: CORICIDIN HBP MAXIMUM STRENGTH COLD, COUGH AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate kit

  • NDC Code(s): 11523-0077-1, 11523-0093-1, 11523-0124-1
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2025

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  • Product Name

    Coricidin HBP Max Strength Cold, Cough, and Flu

  • ACTIVE INGREDIENT

    Active ingredients (in each 30 mL)Purposes
    Acetaminophen 650 mgPain reliever/fever reducer
    Dextromethorphan hydrobromide 20 mgCough suppressant
  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms due to a cold or flu:
      • minor aches and pains
      • headache
      • cough
      • sore throat
    • temporarily reduces fever
  • 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 or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    If a skin or general allergic 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 or any of its ingredients
    • in children under 12 years of age

    Ask a doctor before use if you have

    • liver disease
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough that is accompanied with excessive phlegm (mucus)
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    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.

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than recommended dose
    • adults and children 12 years and over: take 30 mL in the dosing cup provided every 4 hours. Do not exceed 150 mL (5 doses) in 24 hours or as directed by a doctor.
    • children under 12 years of age: do not use
  • OTHER SAFETY INFORMATION

    Other information
    • each 30 mL contains: sodium 38 mg
    • store between 20º to 25ºC (68º to 77ºF)

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, maltitol solution, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • QUESTIONS

    Questions or comments? 1-800-317-2165 (Mon – Fri 9AM – 5PM EST)

  • Product Name

    Coricidin HBP Max Strength Night Cold and Flu

  • ACTIVE INGREDIENT

    Active ingredients (in each 30mL)Purposes
    Acetaminophen 650mgPain reliever/fever reducer
    Dextromethorphan hydrobromide 20mgCough suppressant
    Doxylamine succinate 12.5mgAntihistamine

  • PURPOSE

  • INDICATIONS & USAGE

    • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • sore throat
    • runny nose
    • sneezing

    • temporarily reduces fever
  • 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 or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    If a skin or general allergic 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 to sedate children

    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 or any of its ingredients
    • in children under 12 years of age

    Ask a doctor befpre ise if you have

    • liver disease
    • glaucoma
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem sich as emphysema or chronic bronchitis
    • cough that occurs with excessive phlegm (mucus)
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    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.

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than recommended dose
    • adults and children 12 years and over: take 30 mL in the dosing cup provided every 4 hours. Do not exceed 150 mL (5 doses) in 24 hours or as directed by a doctor.
    • children under 12 years of age: do not use
  • OTHER SAFETY INFORMATION

    Other information
    • each 30 mL contains:     sodium 38 mg
    • store between 20º to 25ºC (68º to 77ºF)

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous sitric acid, FD&C blue #1, FD&C red#40, flavor, glycerin, maltitol solution, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • QUESTIONS

    Questions or comments? 1-800-317-2165 (Mon – Fri 9AM – 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    CORICIDIN HBP MAXIMUM STRENGTH COLD, COUGH AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0124
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0124-11 in 1 CARTON; Type 0: Not a Combination Product05/12/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 355 mL
    Part 21 BOTTLE 355 mL
    Part 1 of 2
    CORICIDIN HBP MAXIMUM STRENGTH COLD, COUGH AND FLU 
    acetaminophen, dextromethorphan hydrobromide liquid
    Product Information
    Item Code (Source)NDC:11523-0093
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    MALTITOL (UNII: D65DG142WK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0093-1355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/27/2022
    Part 2 of 2
    CORICIDIN HBP MAXIMUM STRENGTH NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Item Code (Source)NDC:11523-0077
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    MALTITOL (UNII: D65DG142WK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0077-1355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/12/2025
    Labeler - Bayer HealthCare LLC. (112117283)
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