BACZOL EXPECTORANT- guaifenesin, phenylephrine hcl syrup 
Procaps S.A. de C.V.

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 (Lex)

Drug Facts

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

Phenylephrine HCl  5 mg

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

Phenylephrine ........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 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.

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

Keep out of reach of children.

In case of overdose, contact a physician or 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 ageAsk a doctor

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

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

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

purified water, sodium citrate, sucralose, xanthan gum

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

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 finalpart34106/03/2021
Labeler - Procaps S.A. de C.V. (851259341)

Revised: 8/2023
Document Id: 03ff88e3-61a2-0828-e063-6294a90ab37b
Set id: 8e928b79-2178-47ef-8427-6bb57f143261
Version: 4
Effective Time: 20230828
 
Procaps S.A. de C.V.