Label: COUGH AND COLD- chlorpheniramine maleate and dextromethorphan hydrobromide tablet 

  • NDC Code(s): 59779-411-21
  • Packager: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/13

If you are a consumer or patient please visit this version.

  • Active ingredients (in each tablet)

    Chlorpheniramine maleate 4 mg
    Dextromethorphan HBr 30 mg 

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  • Purpose

    Antihistamine
    Cough suppressant 

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  • 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 
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  • Warnings

    Do not use

    if you are 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

    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • cough that occurs with excessive phlegm (mucus)
    • a breathing problem or presistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, 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 lasts more than 7 days, reoccurs, or occurs with 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 (1-800-222-1222) right away. 

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  • Directions

    • do not exceed recommended dose
    • adults and children 12 years and over: 1 tablet every 6 hours.  Do not take more than 4 tablets in 24 hours
    • children under 12 years: do not use
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    acacia, black iron oxide, calcium carbonate, carnauba wax, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose, magnesium searate, methylparaben, microcrystalline cellulose, povidone,  propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide 

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    CVS
    pharmacy™

    Compare to the active ingredients in Coricidin® HBP Cough & Cold*

    COUGH
    & COLD BP
    ANTIHISTAMINE - CHLORPHENIRAMINE MALEATE
    COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

    Relieves:
    • Cough
    • Runny Nose
    • Sneezing

    DECONGESTANT-FREE

    FOR PEOPLE WITH HIGH BLOOD PRESSURE

    16 TABLETS

    *This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Coricidin® HBP Cough & Cold.
    50844        REV0512E41121

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2011 CVS/pharmacy

    CVS HBP 44-411

    CVS HBP 44-411

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  • INGREDIENTS AND APPEARANCE
    COUGH AND COLD 
    chlorpheniramine maleate and dextromethorphan hbr tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-411
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    CALCIUM CARBONATE  
    CARNAUBA WAX  
    CROSCARMELLOSE SODIUM  
    D&C RED NO. 27  
    LACTOSE  
    MAGNESIUM STEARATE  
    METHYLPARABEN  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    PROPYLPARABEN  
    PROPYLENE GLYCOL  
    SHELLAC  
    SODIUM BENZOATE  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 411
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-411-21 2 in 1 CARTON
    1 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 05/03/2003
    Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(59779-411)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(59779-411)
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