BACZOL EXPECTORANT- guaifenesin and phenylephrine hydrochloride liquid 
Lex Inc

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.

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Baczol ® Expectorant

Drug Facts

Active ingredients (in each 5 mL tsp.)Purpose
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal 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 over2 teaspoonfuls (10 mL), every 4 hours
Children 6 to under 12 years of age1 teaspoonful (5 mL), every 4 hours
Children under 6 years of ageAsk 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

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
BACZOL EXPECTORANT 
guaifenesin and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49523-501
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) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBANANA, CHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49523-501-041 in 1 CARTON02/04/201306/01/2021
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 finalpart34102/04/201306/01/2021
Labeler - Lex Inc (046172888)

Revised: 7/2021
Document Id: c6b30d59-a286-6c3d-e053-2a95a90acc72
Set id: 386312cf-6c7d-4e9d-9ee9-44e0169f0525
Version: 3
Effective Time: 20210709
 
Lex Inc