BACZOL COLD MEDICINE

Manufacturer
Procaps S.A. de C.V.
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:49:12

Label at a glance#

ProductBACZOL COLD MEDICINE
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure18 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL tsp.)
Acetaminophen 250 mg
Dextromethorphan HBr 10 mg
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

Purpose
Acetaminophen .................... Analgesic and Antipyretic
Dextromethorphan HBr ....................Cough Suppressant
Chlorpheniramine Maleate .........................Antihistamine
Phenylephrine HCl ........................ Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses • Temporarily relieves runny nose, sneezing, itching of
the nose or throat, and itchy, watery eyes due to hay fever • nasal
congestion due to the common cold • Calms the cough control
center and relieves coughing • minor aches and pains associated
with the common cold • temporarily reduces fever.

WARNINGS SECTION

Warnings: Liver warning: This product contains
acetaminophen
• Severe liver damage may occur if • adult takes more than 6
doses in 24 hours, which is the maximum daily amount •child
takes more than 6 doses in 24 hours • taken with other drugs
containing acetaminophen• adult has 3 or more alcoholic drinks
every day while using this product • Do not give to children
under 3 years of age or use for more than 10 days unless directed by
a physician.

SPL UNCLASSIFIED SECTION

Stop Use and ask a Doctor if • you have liver disease • pain, cough or nasal congestion gets
worse or lasts more than 5 days (children) or 7 days (adults) • fever gets worse or lasts more
than 3 days • redness or swelling is present • new symptoms occur • you have a breathing
problem such as emphysema or chronic bronchitis • you have glaucoma or difficulty in urination
due to enlargement of the prostate gland • you have shortness of breath, asthma, heart disease,
high blood pressure, thyroid disease, diabetes.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a Doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product, do not exceed recommended dosage. If nervousness, dizziness,
or sleeplessness occur, discontinue use and consult a doctor. May cause excitability especially
in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the
drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving
motor vehicle or operating machinery.

PRECAUTIONS SECTION

Precaution: this product contains FD&C Yellow #5 (Tartrazine) as color additive.

OTC - DO NOT USE SECTION

Do Not Use:If you are now taking a prescription monoamine oxidase 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 your prescription drug contains an
MAOI, ask a doctor or pharmacist before taking this product • with any other drug containing
acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist • if you are allergic to acetaminophen or any of the
inactive ingredients in the product • for persistent or chronic cough such as occurs with smoking,
asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless
directed by a doctor • if you are taking sedatives or tranquilizers, without first consulting your
doctor.

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.

OVERDOSAGE SECTION

Overdose Warning: taking more than recommended
dose (overdose) may cause liver damage. In case of accidental overdose,
contact a physician or Poison Control Center right away. Prompt medical
attention is critical for adults as well as for children even if you do not notice
any signs or symptoms.

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
 1 teaspoon (5 mL) every 4 hours
Children 6 to under 12 years of age 1/2 teaspoon (2.5 mL) every 4 hours
Children under 6 years of age Ask 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 Banana Flavor, cherry flavor, FD&C
yellow #5, glycerin, methyl paraben (as preservative),
polyethylene glycol 400, propyl paraben (as preservative),
purified water, sucralose and Xanthan gum.

OTC - QUESTIONS SECTION

Questions or comments?
customer.service@lablopez.com.sv    754-260-6479

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76864-208-01

Baczol ®
COLD MEDICINE

Acetaminophen • Analgesic and Antipyretic
Dextromethorphan HBr • Cough Suppressant
Chlorpheniramine Maleate • Antihistamine
Phenylephrine HCl • Nasal Decongestant

Fruit Flavor

For sale in the
US only.

SHAKE WELL
BEFORE USE

• Sugar FREE • Alcohol FREE

4 fl.oz. (120 mL)

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

Baczol ® is registered trademark of Laboratorios López, S.A. de C.V.

7  69041 04544  8

Lot:                                                                                                    Rev. 05/2020

Exp. Date:

Baczol BottleBaczol Bottle

Baczol Carton 1Baczol Carton 1

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1370440acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN6
1370440acetaminophen 50 MG/ML / chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD6
1370440acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 per 5 ML Oral SolutionSY6
1370440APAP 50 MG/ML / Chlorpheniramine Maleate 0.8 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML / Phenylephrine Hydrochloride 2 MG/ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76864-208-012023-08-28C16284748780-1f386c649-e5ac-0266-e053-dadaa90a7c1aBACZOL COLD (Lex)
76864-208-012023-01-30C16284748780-1f386c649-e5ac-0266-e053-dadaa90a7c1aBACZOL COLD (Lex)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76864-208-01BACZOL COLD MEDICINE120 mL in 1 BOTTLE, PLASTICSYRUP1206
76864-208-01BACZOL COLD MEDICINE1 in 1 CARTONSYRUP16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76864-208BACZOL COLD MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) SYRUP [PROCAPS S.A. DE C.V.]6Legacy NDC, 2 package rows20241228_9d07b895-27ff-48b4-a597-29782a67a201.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76864-20876864-208-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
570fc736-a325-ebc6-e063-6394a90a1e219d07b895-27ff-48b4-a597-29782a67a2012026-07-20WarningsExact identifier
spl set id: 9d07b895-27ff-48b4-a597-29782a67a201

Reported adverse events (FAERS/openFDA)#

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