Label: BIO DTUSS DMX- brompheniramine maleate, dextromethorphan, pseudoephedrine liquid

  • NDC Code(s): 45737-203-16
  • Packager: Advanced Generic Corporation
  • 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 December 23, 2020

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

  • ACTIVE INGREDIENT

    Active Ingredients(in each 5 mL tsp.)                                               Purpose
    Brompheniramine Maleate...................... 1mg ..................................Antihistamine
    Dextromethorphen HBr........................... 20 mg ............................Cough Suppressant
    Pseudoephedrine HCl............................. 30mg .............................Nasal Decongestant

  • PURPOSE

    Uses:

    • Temporarily relieves cough due to minor throat and bronchial irritation as may occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies or associated with sinusitis
    • Temporarily relieves these symptoms due to hay fever(allergies rhinitis)
    • Runny nose
    • Sneezing
    • Itchy, watery eyes
    • Itchy of the nose or throat
    • Temporarily restores free breathing through the nose
  • WARNINGS


    Warnings:

    • May cause excitability especially in children. May cause drowsiness, alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcohol beverages while taking this product. Do not take this product if you have taken sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
    • Do not exceed recommended dosage. 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.

  • DO NOT USE

    Do Not Use:


    Ask a doctor before use if you have:

    • Cough that occurs with too much phlegm (mucus)
    • Heart disease
    • High blood pressure
    • Thyroid disease
    • Diabetes
    • Glaucoma
    • Trouble urinating due to an enlarged prostate gland
    • A breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    Stop use and ask a doctor if:

    • You get nervous, dizzy or sleepless
    • Symptoms do not get better within 7 days, comes back, or is accompaniend by fever, rash or persistent headache. 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:

     adults and children 12 years of age and over
     take 1 teaspoonfull every 6 hours
     children 6 to under 12 years of age
     take 1/2 teaspoonfull every 6 hours
     children under 6 years of age
     ask doctor

  • INDICATIONS & USAGE

    Other Information:

    store at room temperature 15-30 degrees celcius (59-86 degrees farenheit)

    Tamper Evident Feature Do not use if seal under cap(or cello band over cap) is torn, broken or missing

  • INACTIVE INGREDIENT

    Inactive Ingredients:

     Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sucrose, Citric Acid, Sodium Citrate, D and C Red #33, FD and C Blue #1, Grape Flavor and Purified Water.

  • QUESTIONS

    Question and Comments? 1-305-403-3788

    Advanced Generic Corporation, Miami, FL 33166

    www.advancedgeneric.com

  • PRINCIPAL DISPLAY PANEL

    biodtusslabel

  • INGREDIENTS AND APPEARANCE
    BIO DTUSS  DMX
    brompheniramine maleate, dextromethorphan, pseudoephedrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-203
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SUCROSE (UNII: C151H8M554)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-203-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2011
    Labeler - Advanced Generic Corporation (831762971)
    Registrant - Advanced Generic Corporation (831762971)