Label: ADULT TUSSIN DM LIL DRUG STORE PRODUCTS- 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 November 20, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL)Purposes
    Dextromethorphan HBr 20 mgCough suppressant
    Guaifenesin 200 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)
    • cough that lasts or is chronic such as occurs 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. 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.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • this adult product is not intended for use in children under 12 years of age
    • adults and children 12 years and over: 10 mL every 4 hours
    • children under 12 years: do not use
  • Other information

    • store between 68-77° F (20-25° C). Do not refrigerate.
  • Inactive ingredients

    citric acid, FD&C red #40, flavor, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

  • Questions or comments?

    Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Lil' Drug Store Products, Inc.
    1201 Continental Place NE
    Cedar Rapids, IA 52402

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    QUALITY
    GUARANTEED

    Compare to the Active Ingredients
    in Robitussin® Peak Cold
    Cough + Chest Congestion DM*

    Adult
    Tussin DM

    Dextromethorphan HBr 20 mg, Guaifenesin 200 mg
    Cough Suppressant, Expectorant

    Non-Drowsy Relief of

    • Cough
    • Chest Congestion / Mucus

    For ages 12 years and over

    4 FL OZ
    (118 mL)

    Lil'
    Drug Store®

    Principal Display Panel - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ADULT TUSSIN DM   LIL DRUG STORE PRODUCTS
    dextromethorphan hydrobromide and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6858(NDC:49580-0385)
    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
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    Glycerin (UNII: PDC6A3C0OX)  
    High Fructose Corn Syrup (UNII: XY6UN3QB6S)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Water (UNII: 059QF0KO0R)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6858-41 in 1 CARTON09/09/2016
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/01/2014
    Labeler - Lil' Drug Store Products, Inc (093103646)