BACZOL EXPECTORANT

Manufacturer
Procaps S.A. de C.V.
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:49:09

Label at a glance#

ProductBACZOL EXPECTORANT
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

Phenylephrine HCl  5 mg

OTC - PURPOSE SECTION

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

Phenylephrine ........Nasal Decongestant

INDICATIONS & USAGE SECTION

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

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

WARNINGS SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

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

purified water, sodium citrate, sucralose, xanthan gum

OTC - QUESTIONS SECTION

Questions or Comments?

customer.service@lablopez.com.sv

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Cart209-02 Bacz Cart

Bottle

209-02 Baczol Btl209-02 Baczol Btl

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1370427guaiFENesin 200 MG / phenylephrine hydrochloride 5 MG in 5 mL Oral SolutionPSN5
1370427guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD5
1370427guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76864-209-022023-08-28C16284748780-1f386c649-ca0e-0266-e053-dadaa90a7c1aBACZOL EXPECTORANT (Lex)
76864-209-022023-01-30C16284748780-1f386c649-ca0e-0266-e053-dadaa90a7c1aBACZOL EXPECTORANT (Lex)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76864-209-02BACZOL EXPECTORANT120 mL in 1 BOTTLE, PLASTICSYRUP1205
76864-209-02BACZOL EXPECTORANT1 in 1 CARTONSYRUP15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76864-209BACZOL EXPECTORANT (GUAIFENESIN, PHENYLEPHRINE HCL) SYRUP [PROCAPS S.A. DE C.V.]5Legacy NDC, 2 package rows20241228_8e928b79-2178-47ef-8427-6bb57f143261.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76864-20976864-209-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
570fafbd-dc2b-d737-e063-6394a90a73228e928b79-2178-47ef-8427-6bb57f1432612026-07-20WarningsExact identifier
spl set id: 8e928b79-2178-47ef-8427-6bb57f143261

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.