Label: CVS CHEST CONGESTION RELIEF DM- dextromethorphan hydrobromide / guaifenesin 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 September 29, 2010

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  • ACTIVE INGREDIENT

    Active ingredient - (per tablet)

    Dextromethorphan Hydrobromide   20mg   Cough Suppressant
    Guaifenesin  400mg  Expectorant

  • ASK DOCTOR

    Ask doctor before use if you have

    persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma

    cough is accompanied by excessive phlegm (mucous)

  • STOP USE

    Stop use and ask doctor if

    Symptoms are accompanied by fever, rash or persistent headache

    cough persists for more than 1 week or tends to recur

    A persistent cough may be a sign of a serious condition


  • DO NOT USE

    Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

    Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

    or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains

    an MAIO, ask your doctor or pharmacist before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, In  ase of overdose, get medical help or contact a Poison Center immediately

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • INACTIVE INGREDIENT

    magnesium stearate, microcrystalline cellulose,
     colloidal silicon dioxide, (co) povidone, dicalcium
    phosphate, maltodextrin, sodium starch glycolate, stearic acid

  • DOSAGE & ADMINISTRATION

    Directions        
    • Adults and children 12 years of age and over:    
    take 1 tablet every 4 hours as needed    
    • Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed
    • Children under 6 years of age: consult a doctor    
    Do not exceed 6 doses in a 24 hour period or as directed by a doctor
    Other information store at 15'- 30' C (59'- 86'F)     Rev 10/U9 RCCF

  • INDICATIONS & USAGE

    Uses. temporarily relieves cough due to minor throat and bronchial irritation
    as may occur with a common cold • helps loosen phlegm (mucus) and thin
    bronchial secretions to rid the bronchial passageways of bothersome mucus
    • helps make coughs more productive

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

  • WARNINGS

    Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

    Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

    or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains

    an MAIO, ask your doctor or pharmacist before using this product.
  • PRINCIPAL DISPLAY PANEL

    package labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    CVS CHEST CONGESTION RELIEF  DM
    dextromethorphan hydrobromide / guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE, COLLOIDAL (UNII: ETJ7Z6XBU4)  
    COPOVIDONE (UNII: D9C330MD8B)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code PH073
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10956-003-011 in 1 CARTON
    1NDC:10956-003-6060 in 1 BOTTLE, PLASTIC
    2NDC:10956-003-011 in 1 CARTON
    2NDC:10956-003-9090 in 1 BOTTLE, PLASTIC
    3NDC:10956-003-011 in 1 CARTON
    3NDC:10956-003-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/07/2009
    Labeler - Reese Pharmaceutical Co (004172052)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest557054835manufacture
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