Label: BREACOLD ADULT- guaifenesin, dextromethorphan hbr 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 10mL tsp)

    Guaifenesin 200 mg………………………………Expectorant

    Dextromethorphan HBr 20 mg…………………….Cough suppressant

  • Purpose

    Expectorant

    Cough Suppressant

  • Uses

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

  • Do not exceed recommended dosage.

    A persistent 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 bronchitis, or emphysema, or where 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.

  • 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

  • Other information

    • Store this product between 15°-30°C (59°-86°F)
  • Inactive ingredients

    Citric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben,raspberry flavor, sucrose, water

  • PRINCIPAL DISPLAY PANEL

    breacold adult

  • INGREDIENTS AND APPEARANCE
    BREACOLD ADULT 
    guaifenesin, dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    RASPBERRY (UNII: 4N14V5R27W)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-040-041 in 1 CARTON02/21/2012
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/21/2012
    Labeler - Menper Distributors, Inc. (101947166)