Baczol

Manufacturer
Procaps S.A. de C.V.
Effective date
2024-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:11:10

Label at a glance#

ProductBaczol Antigripal
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, (+/-)-, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure9 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: minor aches and pain sore throat headache stuffy nose nasal congestion cough due to minor throat and bronchial irritation and temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

only use the dosing cup provided shake well before use if you are taking other cold/flu products, read complete labeling before dosing adults & children 12 years of age and older 20mL every 4 hours, do not exceed 6 doses per 24 hours children 6 to under 12 years of age 10mL every 4 hours, do not exceed 5 doses per 24 hours children under 6 years of age do not use

Label contents#

Full prescribing information#

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 10 mL)Purposes
Acetaminophen 325 mg ........Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg ........Cough suppressant
Guaifenesin 200 mg........ Expectorant
Phenylephrine HCL 5 mg ........ Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

  • minor aches and pain
  • sore throat
  • headache
  • stuffy nose
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • and temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if  adults take more than

6 doses in 24 hours, which is the maximum daily amount

  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever,

headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • 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 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.

A​sk a doctor before use if the user has a

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that is accompanied by excessive
  • phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged
  • prostate gland

Ask a doctor or pharmacist before use if the user is

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

Ask a doctor before use if the user

OTC - ASK DOCTOR SECTION

  • is a child with pain of arthritis

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • redness or swelling is present
  • pain 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
  • any new symptoms occur
  • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent

headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • only use the dosing cup provided
  • shake well before use
  • if you are taking other cold/flu products, read complete labeling before dosing
adults & children 12 years of age and older20mL every 4 hours, do not exceed 6 doses per 24 hours
children 6 to under 12 years of age10mL every 4 hours, do not exceed 5 doses per 24 hours
children under 6 years of agedo not use

Other information

OTHER SAFETY INFORMATION

  • each 10 mL contains: sodium 10mg
  • store between 68-77°F (20-25°C)
  • do not refrigerate

DO NOT USE IF SAFETY SEAL UNDER CAP IMPRINTED WITH” SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or Comments?

OTC - QUESTIONS SECTION

+1-754-260-6479 (M-F) 9 AM to 5 PM EST or customer.service@sofgenpharma.com

Mfg. for: & Dist by:

SPL PATIENT PACKAGE INSERT SECTION

Mfg. for/ Fdo. para:

PROCAPS GROUP

Boulevard de Ejercito Nacional, Km. 5 1/2, Soyapango,

San Salvador, El Salvador, C.A.

Baczol® is a registered trademark of Procaps S.A. De C.V.

Dist. by/ por:

Sofgen Pharmaceuticals LLC

21500 Biscayne Boulevard Ste. 600, Aventura, FL 33180

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Baczol ExpectorantBaczol Expectorant

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76864-22076864-220-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
2a873f87-596e-9441-e063-6394a90a424c118174d5-d4a4-005e-e063-6394a90acd742024-12-30WarningsExact identifier
spl set id: 118174d5-d4a4-005e-e063-6394a90acd74

Reported adverse events (FAERS/openFDA)#

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