BACZOL EXPECTORANT- dextromethorphan, guaifenesin liquid

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]

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

INGREDIENTS AND APPEARANCE

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
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

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