Label: PREMIER VALUE- dextromethorphan hbr, guaifenesin solution

  • NDC Code(s): 68016-744-04
  • Packager: PHARMACY VALUE ALLIANCE LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 6, 2023

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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 200 mg

  • Purposes

    Cough suppressant

    Expectorant

  • 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 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

    ▪
    shake well before using
    ▪
    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

    20 mL every 4 hours

    children under 12 years

    do not use
  • Other information

    ▪
    store at room temperature. Do not refrigerate.
    ▪
    Alcohol-free
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

  • Questions or comments?

    1-866-467-2748

  • Package/Label Principal Display Panel

    Compare to the active ingredients of Robitussin® Sugar Free Cough + Congestion DM

    NDC# 68016-744-04

    Premier Value®

    Sugar Free

    Tussin DM

    Cough Suppressant

    Dextromethorphan HBr

    Expectorant

    Guaifenesin

    •
    Relieves Chest Congestion
    •
    Controls cough and mucus

    Specially Formulated for DIABETICS

    Non-Drowsy

    For Ages 12 & Over

    4 FL OZ (118 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    Distributed By:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Sugar Free Cough + Congestion DM.

    Premier Value Sugar Free Tussin DM
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-744
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-744-041 in 1 CARTON03/20/2019
    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 DrugM01203/20/2019
    Labeler - PHARMACY VALUE ALLIANCE LLC (101668460)
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