Label: TUSSIN DM- dextromethorphan hydrobromide and guaifenesin liquid

  • 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 December 30, 2013

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  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL tsp):Purpose
    Dextromethorphan HBr, USP 10 mgCough suppressant
    Guaifenesin, USP 100 mgExpectorant
  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold; helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

  • 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) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    Do not exceed recommended dose

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, 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.

  • Other information

    Each tsp contains: sodium 6.5 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate.

    Dosage cup provided.

  • Inactive ingredients

    citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • Directions

    do not take more than 6 doses in any 24-hour period

    • this adult product is not intended for use in children under 12 years of age
    • mL = milliliter; tsp = teaspoonful
    agedose
    adults and children 12 years and over10 mL (2 tsp) every 4 hours
    children under 12 yearsdo not use
  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    davAgen
    Pharmaceutical LLC
    Somerset, NJ 08873

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    davAgen
    pharmaceutical

    NDC 76140-106-08

    Adults & Children Ages 12 & Older

    Tussin DM
    Cough &
    Chest Congestion

    Cough Suppressant - Dextromethorphan HBr
    Expectorant - Guaifenesin

    For Relief of:

    • Cough
    • Chest Congestion & Mucus

    8 FL OZ (237 mL)

    Principal Display Panel - 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TUSSIN DM 
    dextromethorphan hydrobromide and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76140-106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sorbitol (UNII: 506T60A25R)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Menthol (UNII: L7T10EIP3A)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorTROPICAL FRUIT PUNCH, ORANGE, MENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76140-106-081 in 1 CARTON
    1236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/10/2013
    Labeler - davAgen Pharmaceutical, LLC (967545935)
    Establishment
    NameAddressID/FEIBusiness Operations
    davAgen Pharmaceutical, LLC967545935MANUFACTURE(76140-106) , PACK(76140-106) , LABEL(76140-106) , ANALYSIS(76140-106)
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