Label: DG HEALTH ADULT TUSSIN MULTI SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

  • 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 April 23, 2021

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  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 200 mg

    Phenylephrine HCl, USP 10 mg

  • Purposes

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    •
    temporarily relieves these symptoms occurring with a cold:
    •
    nasal congestion
    •
    cough due to minor throat and bronchial irritation
  • 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

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland
    •
    cough that occurs with too much phlegm (mucus)
    •
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    •
    you get nervous, dizzy, or sleepless
    •
    symptoms do not get better within 7 days or are accompanied by fever
    •
    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

  • Directions

    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosing cup provided
    •
    keep dosing cup with product
    •
    mL = milliliter
    •
    this adult product is not intended for use in children under 12 years of age

    age

    dose

    adults and children 12 years and over

    10 mL every 4 hours

    children under 12 years

    do not use
  • Other information

    •
    each 10 mL contains: sodium 5 mg
    •
    store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • Questions or comments?

    1-888-309-9030

  • Principal Display Panel

    Compare to the active ingredients of Robitussin® Multi-Symptom Cold

    For Ages 12 & Over

    Adult

    Tussin

    Dextromethorphan HBr

    Cough Suppressant

    Guaifenesin

    Expectorant

    Phenylephrine HCl

    Nasal Decongestant

    Multi-Symptom Cold

    Relieves:

    Cough

    Nasal Congestion

    Mucus

    Non Drowsy

    CF

    4 FL OZ (118 mL)

    Adult Tussin Carton
  • INGREDIENTS AND APPEARANCE
    DG HEALTH ADULT TUSSIN MULTI SYMPTOM COLD 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-980
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED (clear) Score    
    ShapeSize
    FlavorFRUIT (Menthol) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-980-261 in 1 CARTON11/09/2018
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/09/2018
    Labeler - Dolgencorp, LLC (068331990)
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