Label: CORICIDIN HBP MAXIMUM STRENGTH MULTI SYMPTOM FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide tablet

  • NDC Code(s): 11523-0038-1, 11523-0038-2
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 24, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Coricidin HBP

    Maximum Strength Multi-Symptom Flu

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Active ingredients (in each tablet) Purposes

    Acetaminophen 325 mg………………….………….Pain reliever/fever reducer

    Chlorpheniramine maleate 2 mg……….......................................Antihistamine

    Dextromethorphan hydrobromide 10 mg…………………..Cough suppressant

  • PURPOSE

  • Uses

    Uses

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

    Liver warning

    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

    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

    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

    Ask a doctor before use if you have

    • liver disease
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with excessive phlegm (mucus)
    • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    When using this product

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

    Ask a doctor or pharmacist before use if you are

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

    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. Abuse of this product can lead to serious injury.

    Overdose warning

    Overdose warning: Taking more than the recommended dose may cause liver damage. 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 children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    do not use more than directed (see overdose warning)

    adults and children 12 years and over: take 2 tablets every 4 hours, while symptoms persist. Do not take more than 10 tablets in 24 hours or as directed by a doctor.

    children under 12 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    store at room temperature. Avoid excessive heat.

  • INACTIVE INGREDIENT

    Inactive ingredients FD&C red #40 aluminum lake, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • QUESTIONS

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

  • Carton

    NDC 11523-0038Coricidin®

    HBP COLD RELIEF FOR PEOPLE WITH

    HIGH BLOOD PRESSUREƗ

    MAXIMUM STRENGTH

    MULTI-SYMPTOM

    FLU

    Relieves

    • Body Aches & Pains
    • Headache
    • Fever
    • Cough
    • Runny Nose & Sneezing
    • Sore Throat

    ƗDecongestant Free

    24 tablets

    Acetaminophen - Pain Reliever/Fever Reducer

    Chlorpheniramine Maleate - Antihistamine

    Dextromethorphan HBr - Cough Supressant

    LEARN MORE

    American Heart Association

    Information Enclosed

  • INGREDIENTS AND APPEARANCE
    CORICIDIN HBP MAXIMUM STRENGTH MULTI SYMPTOM FLU 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0038
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code c;flu
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0038-11 in 1 CARTON09/04/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-0038-22 in 1 CARTON09/04/2020
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2020
    Labeler - Bayer HealthCare LLC. (112117283)