Label: BIODESP DM- dextromethorphan, guaifenesin, phenylephrine liquid

  • NDC Code(s): 45737-221-16
  • Packager: Advanced Generic Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients: (in each 5 mL tsp.)              Purpose

    Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

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

    Phenylephrine HCl 5 mg.................................. Decongestant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms due to the common cold. hay fever (allergic rhinitis), or other upper respiratory allergies;
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bonchial tubes and make coughs more productive
    • nasal congestion
    • reduces swelling of nasal passages
  • WARNINGS

    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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.

    When using this product do not exceed recommended dosage

    Ask a doctore before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to enlarged prostate gland
    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • cough lasts for more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts. These could be signs of a serious condition
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions Do not exceed 4 doses in 24 hours.

     adults and children 12 years of age and overtake 2 teaspoonfuls (10 mL) every 6 hours 
    children 6 to under 12 years of age take 1 teaspoonful (5 mL) every 6 hours 
    children 2 to under 6 years of age take 1/2 teaspoonful (2.5 mL) every 6 hours 
    children under 2 years of age ask a doctor 

  • QUESTIONS

    Questions or comments?1-305-403-3788
    Manufactured For: Advanced Generic Corporation, Miami, FL 33147.
    www.advancedgeneric.com

  • INACTIVE INGREDIENT

    Inactive ingredientsartificial flavor, citric acid, methylparaben, propylene glycol,
    propylparaben, purified water, sodium citrate and sucralose.

  • PRINCIPAL DISPLAY PANEL

    BiodespDMLabel

  • INGREDIENTS AND APPEARANCE
    BIODESP  DM
    dextromethorphan, guaifenesin, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-221-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/2009
    Labeler - Advanced Generic Corporation (831762971)