FDA.reportPublic FDA data

Baczol

Manufacturer
Procaps S.A. de C.V.
Effective date
2024-02-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:11:10

Label at a glance#

ProductBaczol Expectorant
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

Temporarily relieves common cold symptoms: cough due to minor throat & bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

only use the dosing cup provided do not exceed 6 doses in a 24-hour period Age Dose adults and children 12 years and older 20mL every 4 hours children 6 to 12 years 10mL every 4 hours children under 6 years do not use

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

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

Phenylephrine HCl  5 mg

OTC - PURPOSE SECTION

Active ingredients (in each 10 mL)

Purposes

Dextromethorphan HBr 10mg .........

Cough suppressant

Guaifenesin 200 mg.......

Expectorant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold symptoms:

  • cough due to minor throat & bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

  • cough that is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough persists for more than 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • only use the dosing cup provided
  • do not exceed 6 doses in a 24-hour period
AgeDose
adults and children 12 years and older20mL every 4 hours
children 6 to 12 years10mL every 4 hours
children under 6 yearsdo not use

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, 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#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76864-22176864-221-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
D&C RED NO. 339DBA0SBB0LIACT
DEXTROSEIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
2a878c11-91ce-87aa-e063-6294a90a5c4b0b66a67f-3b54-e7ed-e063-6294a90a2f322024-12-30WarningsExact identifier
spl set id: 0b66a67f-3b54-e7ed-e063-6294a90a2f32

Reported adverse events (FAERS/openFDA)#

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