TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [DAVAGEN PHARMACEUTICAL, LLC]

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TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [DAVAGEN PHARMACEUTICAL, LLC]
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NDC 76140-106-08
Set ID 3a101213-5d6a-4f20-8f67-2dcda375d73b
Category HUMAN OTC DRUG LABEL
Packager davAgen Pharmaceutical, LLC
Generic Name
Product Class
Product Number
Application Number PART341
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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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