Label: DIABETIC 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 February 6, 2018

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

View All Sections
  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 10 mg

    Guaifenesin 100 mg

  • Purposes

    Cough Suppressant

    Expectorant

  • Uses

    • temporarily relieves cough
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
  • 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 two 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

    • a cough that occurs with too much phlegm (mucus)
    • a chronic cough that lasts or 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 occurs with fever, rash, or headache that lasts

    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.

  • Directions

    • take every 4 hours
    • do not exceed 6 doses in 24 hours
    adults & children 12 years & over 10 mL (2 teaspoonfuls)
    children 6 years to under 12 years5 mL (1 teaspoonful)
    children 2 years to under 6 years2.5 mL (½ teaspoonful)
    children under 2 yearsask a doctor
  • Other information

    Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

    Storage

    • store at room temperature 20-25ºC (68-77ºF)
    • keep tightly closed
  • Inactive ingredients

    Acesulfame potassium, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

  • Questions and comments?

    Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST.

    Serious side effects associated with use of this product may be reported to this number.

  • HOW SUPPLIED

    Product: 68151-0062

    NDC: 68151-0062-1 5 mL in a CUP, UNIT-DOSE

  • DIABETIC TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID

    Label Image
  • INGREDIENTS AND APPEARANCE
    DIABETIC TUSSIN DM 
    dextromethorphan hydrobromide and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68151-0062(NDC:61787-062)
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CHERRY (UNII: BUC5I9595W)  
    VANILLA (UNII: Q74T35078H)  
    ASPARTAME (UNII: Z0H242BBR1)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68151-0062-15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product12/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/1997
    Labeler - Carilion Materials Management (079239644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carilion Materials Management079239644REPACK(68151-0062)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!