Label: COUGH AND CONGESTION DM- dextromethorphan and guaifenesin capsule, liquid filled

  • 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 September 6, 2016

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  • Active Ingredient

    (in each liquid filled capsule)

    Dextromethorphan Hydrobromide, USP 10mg

    Guaifenesin, USP 200mg

  • Purpose

    Cough Suppressant

    Expectorant

  • Uses

    • Temporarily relieves cough due minor throat and bronchial irritation as may occur with a cold
    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Directions

    • Do not take more than 12 capsules in any 24 hour period
    • This adult product is not intend for use in children under 12 years of age
                                 Age              dose
      Adults and children 12 years and over2 capsules every 4 hours
      Children under 12 yearsDo not use
  • 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.

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm(mucus)
    • cough that lasts or is chronic such as occur with smoking, asthma, chronic bronchitis, or emphysema

      Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. This 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.

  • Other Information

    • store at 20-25 °C(68-77 °F)
    • avoid excessive heat above 40 °C (104°F)
  • Inactive Ingredients

    FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide

  • Questions or Comments

    Toll free 1-855-314-1850

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    570864db-figure-01

    Cough and Congestion DM,

    NDC:76168-060-37  16 Softgel Liquid filled

  • INGREDIENTS AND APPEARANCE
    COUGH AND CONGESTION DM 
    dextromethorphan and guaifenesin capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POVIDONE (UNII: FZ989GH94E)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorRED (Light) Scoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 601
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-060-3716 in 1 BOTTLE11/08/2015
    11 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/08/2015
    Labeler - Velocity Pharma (962198409)
    Registrant - Velocity Pharma (962198409)