Label: BACZOL EXPECTORANT- guaifenesin, phenylephrine hcl syrup

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

Drug Label Information

Updated December 27, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

    Phenylephrine HCl  5 mg

  • PURPOSE

    Purpose
    Guaifenesin .....................Expectorant

    Phenylephrine ........Nasal Decongestant

  • INDICATIONS & USAGE

    Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain

    bronchial tubes • temporarily relieves nasal congestion due to the common cold.

  • WARNINGS

    Warnings: • Do not exceed recommended dosage  If nervousness,
    dizziness, or sleeplessness occurs, discontinue use and consult a
    doctor.

    Do not use this product • for persistant or chronic cough, such as
    occurs with smoking, asthma, chronic bronchitis, or emphysema, or if
    cough is accompanied by excessive phlegm (mucus), unless directed
    by a Doctor • if you are now taking a prescription Monoamineoxidase
    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 a doctor or a pharmacist before taking this product.
    • if you have heart disease, high blood pressure, thyroid disease, diabetes,
    or difficulty in urination due to enlargement of the prostate gland unless
    directed by a Doctor.

    Stop use and ask a Doctor • A persistent cough may be a sign of a
    serious condition; • If cough persists for more than one week, tend to
    recur, or is accompanied by fever, rash or persistent headache; • if
    symptoms do not improve within 7 days or are accompanied by fever.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, contact a physician or Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions  Do not exceed more than 6 doses for children and adults
    in a 24 - hour period.

    Adults and Children

    12 years of age and over

    2 teaspoonfuls (10 mL)

    every 4 hours

    Children 6 to under

    12 years of age

    1 teaspoonful (5 mL)

    every 4 hours

    Children under 6 years of ageAsk a doctor

  • OTHER SAFETY INFORMATION

    Other information • Store at room temperature 15º-30ºC (59º-86ºF).
    Tamper evident: Do not use if there is evidence of tampering.

  • INACTIVE INGREDIENT

    Inactive ingredients: citric acid, glycerin, garpe flavor, methylparaben

    (as preservative), propylene glycol, propylparaben (as preservative),

    purified water, sodium citrate, sucralose, xanthan gum

  • QUESTIONS

    Questions or Comments?

    customer.service@lablopez.com.sv

  • Product Labeling

    NDC 76864-209-02

    Baczol ®
    EXPECTORANT

    Guaifenesin • Expectorant
    Phenylephrine HCl • Nasal Decongestant

    Fruit Flavor

    • Sugar FREE

    • Alcohol FREE

    4 fl. oz.

    Manufactured For: Laboratorios López, S.A. de C.V.
    Boulevard del Ejército Nacional, Km. 5 1/2,
    Soyapango, San Salvador,, El Salvador, C.A.

    Lot:                                                                                                    Rev. 07/2020

    Exp. Date:

    Carton

    209-02 Bacz Cart

    Bottle

    209-02 Baczol Btl

    res

  • INGREDIENTS AND APPEARANCE
    BACZOL EXPECTORANT 
    guaifenesin, phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76864-209
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76864-209-021 in 1 CARTON06/03/2021
    1120 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 DrugM01206/03/2021
    Labeler - Procaps S.A. de C.V. (851259341)