Label: BISOLVINE ADULT- guaifenesin, dextromethorphan 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 18, 2022

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  • Active Ingredients (in each 10 mL) Purpose

    Dextromethorphan 20 mg.............................................. Cough Suppressant

    Guaifenesin 200 mg ...................................................... Expectorant

  • Purpose 

    Cough Suppressant

    Expectorant

  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

  • Warnings

    Do not exceed recommended dosage.
    A persistent or chronic cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

  • Do not use:

    • this product for persistent or chronic cough, such as occurs with smoking, asthma, chronic brochitis or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

    * 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not exceed 6 doses in 24 hours

     Age Dose
     Adults and Children 12 years of age and over 2 teaspoonfuls (10 ml) every 4 hours
     Children under 12 years of age Do not use 

  • Inactive ingredients

    artificial strawberry-banana flavor, citric acid, fd&c red #40, glycerin, methyl paraben, propylene glycol, propylparaben, sucrose, water

  • Questions?

    Questions? call 1-800-560-5523 M-F 9 AM to 4 PM Eastern.

  • PRINCIPAL DISPLAY PANEL

    bisolvine adultbisolvine adult

  • INGREDIENTS AND APPEARANCE
    BISOLVINE  ADULT
    guaifenesin, dextromethorphan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-325
    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
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorSTRAWBERRY (Strawberry -Banana Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-325-041 in 1 CARTON02/01/2010
    1120 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 finalpart34102/01/2010
    Labeler - MENPER DISTRIBUTORS INC. (101947166)
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