Label: BISOLVINE CHILD- 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 August 26, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL)                  Purpose

    Guaifenesin 100 mg ................................................ Expectorant

    Dextromethorphan.............................................. Cough Suppressant

  • PURPOSE

    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

    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

    Do not use:

        * this product for persistent or chronic cough, such as occurs with smoking, asthma, 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.

  • Other Information

    Other Information

    •    store this product between (15 to 30 C) (59 to 86 C)
    Distributed by Menper Distributors, Inc.
         6500 N.W. 35th Ave., Miami, Fl, 33147
               www.menperdistributors.com
  • INACTIVE INGREDIENT


  • Directions

    Directions  


    • Do not exceed 6 doses in 24 hours

    Age                                                                    Dose

    Children 6 to under                               1 tablespoonful (15 mL)
    12 years of age                                    every 4 hours


    Children 2 to under                               1/2 tablespoonful (7.5 mL)
    6 years of age                                      every 4 hours


    Children under 2 years of age                Consult your doctor

  • PRINCIPAL DISPLAY PANEL

    BisolvineChileLabel

  • INGREDIENTS AND APPEARANCE
    BISOLVINE  CHILD
    guaifenesin, dextromethorphan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14505-488
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE100 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRY (Strawberry -Banana Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14505-488-04120 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/18/2010
    Labeler - Pharmalab Enterprises Inc. (174401088)
    Registrant - Pharmalab Enterprises Inc. (174401088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmalab Enterprises Inc.174401088manufacture