BACZOL EXPECTORANT (G) (DA)

Baczol by

Drug Labeling and Warnings

Baczol by is a Otc medication manufactured, distributed, or labeled by Procaps S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BACZOL EXPECTORANT- dextromethorphan, guaifenesin liquid 
Procaps S.A. de C.V.

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BACZOL EXPECTORANT (G) (DA)

Drug Facts

Drug Facts

Active Ingredients & Purposes

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

Phenylephrine HCl  5 mg

• Active ingredients (in each 10 mL): Purposes
• Dextromethorphan HBr 10mg .........:

  Cough suppressant

• Guaifenesin 200 mg.......:

  Expectorant

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

Warnings

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.

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

• 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

• 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,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• 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

Other information

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

Inactive ingredients

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?

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

Mfg. for: & Dist by:

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

BACZOL  EXPECTORANT
dextromethorphan, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76864-221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76864-221-04	1 in 1 CARTON	12/01/2023	01/01/2024
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/01/2023	01/01/2024

Labeler - Procaps S.A. de C.V. (851259341)

Revised: 12/2024

Document Id: 2a878c11-91ce-87aa-e063-6294a90a5c4b

34390-5

Set id: 0b66a67f-3b54-e7ed-e063-6294a90a2f32

Version: 3

Effective Time: 20241230