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#
Contacts and useful links#
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
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:
res
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1370440 | acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | 6 |
| 1370440 | acetaminophen 50 MG/ML / chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | 6 |
| 1370440 | acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 per 5 ML Oral Solution | SY | 6 |
| 1370440 | APAP 50 MG/ML / Chlorpheniramine Maleate 0.8 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML / Phenylephrine Hydrochloride 2 MG/ML Oral Solution | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76864-208-01 | 2023-08-28 | C162847 | 48780-1 | f386c649-e5ac-0266-e053-dadaa90a7c1a | BACZOL COLD (Lex) |
| 76864-208-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-e5ac-0266-e053-dadaa90a7c1a | BACZOL COLD (Lex) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76864-208-01 | BACZOL COLD MEDICINE | 120 mL in 1 BOTTLE, PLASTIC | SYRUP | 120 | 6 | |
| 76864-208-01 | BACZOL COLD MEDICINE | 1 in 1 CARTON | SYRUP | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76864-208 | BACZOL COLD MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) SYRUP [PROCAPS S.A. DE C.V.] | 6 | Legacy NDC, 2 package rows | 20241228_9d07b895-27ff-48b4-a597-29782a67a201.zip |
Products#
Every source-derived product name is available through these pages.
- BACZOL COLD MEDICINE
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl
- FD&C YELLOW NO. 5
- GLYCERIN
- METHYLPARABEN
- POLYETHYLENE GLYCOL 400
- PROPYLPARABEN
- WATER
- SUCRALOSE
- XANTHAN GUM
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76864-208 | 76864-208-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 570fc736-a325-ebc6-e063-6394a90a1e21 | 9d07b895-27ff-48b4-a597-29782a67a201 | 2026-07-20 | Warnings | 9d07b895-27ff-48b4-a597-29782a67a201 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

