Label: CORICIDIN HBP COUGH AND COLD- chlorpheniramine maleate, dextromethorphan hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 May 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purpose

    Chlorpheniramine maleate 4 mg………………………….....................Antihistamine

    Dextromethorphan hydrobromide 30 mg……………………… .Cough suppressant

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves runny nose and sneezing due to the common cold
  • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • in children under 12 years of age

    Do not use to sedate children.

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    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

    Stop use and ask a doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. 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. Abuse of this product can lead to serious injury.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not exceed recommended dose
    • adults and children 12 years and over: take 1 tablet every 6 hours, not more

    than 4 tablets in 24 hours

    • children under 12 years of age: do not use
  • OTHER SAFETY INFORMATION

    Other information

    • store between 20º to 25ºC (68º to 77ºF)
    • see end flap for expiration date and lot number
  • INACTIVE INGREDIENT

    Inactive ingredients croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

  • QUESTIONS

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

  • Carton 16

    NDC 11523-0008-1Coricidin®

    HBP

    Decongestant-Free Cold

    Symptom Relief for

    People with High Blood Pressure

    Cold and Cough

    Dextromethorphan HBr-

    Cough Suppresant

    Chlorpheniramine Maleate-

    Antihistamine

    Relieves:

    • Cough
    • Runny nose
    • Sneezing

    16 TABLETS

  • INGREDIENTS AND APPEARANCE
    CORICIDIN HBP COUGH AND COLD 
    chlorpheniramine maleate, dextromethorphan hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code CC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0008-12 in 1 CARTON10/23/2020
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/23/2020
    Labeler - Bayer HealthCare LLC. (112117283)
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