Label: BACZOL EXPECTORANT- dextromethorphan, guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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

View All Sections
  • Drug Facts

    Drug Facts

  • Active Ingredients & Purposes

    Active ingredients (in each 5 mL tsp.)
    Guaifenesin 200 mg

    Phenylephrine HCl  5 mg

    Active ingredients (in each 10 mL)

    		Purposes

    Dextromethorphan HBr 10mg .........

    Cough suppressant

    Guaifenesin 200 mg.......

    Expectorant

  • Uses

    Temporarily relieves common cold symptoms:

    • cough due to minor throat & bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    A​sk a doctor before use if the user has a

    • cough that is accompanied by excessive phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema

    Stop use and ask a doctor if

    • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • only use the dosing cup provided
    • do not exceed 6 doses in a 24-hour period
    AgeDose
    adults and children 12 years and older20mL every 4 hours
    children 6 to 12 years10mL every 4 hours
    children under 6 yearsdo not use

  • Other information

    • each 10 mL contains: potassium 10mg, sodium 10mg
    • store between 68-77°F (20-25°C)
    • do not refrigerate
  • Inactive ingredients

    citric acid anhydrous, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum.

  • Questions or Comments?

    +1-754-260-6479 (M-F) 9 AM to 5 PM EST or customer.service@sofgenpharma.com

  • Mfg. for: & Dist by:

    Mfg. for/ Fdo. para:

    PROCAPS GROUP

    Boulevard de Ejercito Nacional, Km. 5 1/2, Soyapango,

    San Salvador, El Salvador, C.A.

    Baczol® is a registered trademark of Procaps S.A. De C.V.

    Dist. by/ por:

    Sofgen Pharmaceuticals LLC

    21500 Biscayne Boulevard Ste. 600,

    Aventura, FL 33180

  • Principal Display Panel

    Baczol Expectorant

  • INGREDIENTS AND APPEARANCE
    BACZOL  EXPECTORANT
    dextromethorphan, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76864-221
    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 HYDROBROMIDE10 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76864-221-041 in 1 CARTON12/01/2023
    1118 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 DrugM01212/01/2023
    Labeler - Procaps S.A. de C.V. (851259341)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!