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Baczol Expectorant (Lex Inc)

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LIQUID 1 BOTTLE in 1 CARTON (49523-501-04) > 120 mL in 1 BOTTLE Label Information

Complete Baczol Expectorant Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL tsp.) Purpose
    Guaifenesin 200 mg Expectorant
    Phenylephrine HCl 5 mg Nasal Decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves nasal congestion due to the common cold.

  • Warnings

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

    Do not use this product
    • for persistent 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 Monoaminooxidase 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 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 persist 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.

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

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


  • 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 age Ask a doctor

  • Other information

    • Store at room temperature 15°-30°C (59°-86°F).

    Tamper evident

    Do not use if there is evidence of tampering.


  • Inactive ingredients

    Banana flavor, cherry flavor, citric acid, hidrogenated castor oil, magnesium aluminum silicate, methyl paraben (as preservative), propylene glycol, propyl paraben (as preservative), purified water, silicon dioxide, sorbitol, sucralose, titanium dioxide, vanillin flavor, xanthan gum.


  • Questions or comments?

    1-888-795-4540


  • SPL UNCLASSIFIED SECTION

    Distributed in the USA by:
    PLAZA IZALCO WHOLESALE
    417, Clifford Avenue, Alexandria VA, 22305


  • PRINCIPAL DISPLAY PANEL - 120 ml Bottle Carton

    NDC 49523-501-04

    Baczol®

    EXPECTORANT

    Guaifenesin Expectorant
    Phenylephrine HCl Nasal Decongestant

    Fruit Flavor


    • Sugar FREE
    • Alcohol FREE

    4 fl. oz.

    Laboratorios López

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

    Principal Display Panel - 120 ml Bottle Carton

  • INGREDIENTS AND APPEARANCE
    BACZOL EXPECTORANT 
    guaifenesin and phenylephrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49523-501
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VANILLIN (UNII: CHI530446X)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BANANA, CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49523-501-04 1 in 1 CARTON
    1 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 02/04/2013
    Labeler - Lex Inc (046172888)
    Establishment
    Name Address ID/FEI Business Operations
    Lex Inc 046172888 MANUFACTURE(49523-501)