BACZOL EXPECTORANT- guaifenesin, phenylephrine hcl syrup

BACZOL EXPECTORANT by

Drug Labeling and Warnings

BACZOL EXPECTORANT 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Phenylephrine HCl  5 mg

PURPOSE

Purpose
Guaifenesin .....................Expectorant

Phenylephrine ........Nasal Decongestant

INDICATIONS & USAGE

Uses  helps loosen phlegm (mucus) and thin bronchial secretions to drain

bronchial tubes  temporarily relieves nasal congestion due to the common cold.

WARNINGS

Warnings: Do not exceed recommended dosage  If nervousness,
dizziness, or sleeplessness occurs, discontinue use and consult a
doctor.

Do not use this product for persistant or chronic cough, such as
occurs with smoking, asthma, chronic bronchitis, or emphysema, or if
cough is accompanied by excessive phlegm (mucus), unless directed
by a Doctor if you are now taking a prescription Monoamineoxidase
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 you are taking a prescription drug that
contains an MAOI, ask a doctor or a pharmacist before taking this product.
if you have heart disease, high blood pressure, thyroid disease, diabetes,
or difficulty in urination due to enlargement of the prostate gland unless
directed by a Doctor.

Stop use and ask a Doctor A persistent cough may be a sign of a
serious condition; If cough persists for more than one week, tend to
recur, or is accompanied by fever, rash or persistent headache; if
symptoms do not improve within 7 days or are accompanied by fever.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, contact a physician or Poison Control Center right away.

DOSAGE & ADMINISTRATION

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:

  2 teaspoonfuls (10 mL)

  every 4 hours

• Children 6 to under 12 years of age:

  1 teaspoonful (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

Inactive ingredients: citric acid, glycerin, garpe flavor, methylparaben

(as preservative), propylene glycol, propylparaben (as preservative),

purified water, sodium citrate, sucralose, xanthan gum

QUESTIONS

Questions or Comments?

customer.service@lablopez.com.sv

Product Labeling

NDC: 76864-209-02

Baczol ®
EXPECTORANT

Guaifenesin Expectorant
Phenylephrine HCl Nasal Decongestant

Fruit Flavor

Sugar FREE

Alcohol FREE

4 fl. oz.

Manufactured For: Laboratorios López, S.A. de C.V.
Boulevard del Ejército Nacional, Km. 5 1/2,
Soyapango, San Salvador,, El Salvador, C.A.

Lot:                                                                                                    Rev. 07/2020

Exp. Date:

Carton

Bottle

res

INGREDIENTS AND APPEARANCE

BACZOL EXPECTORANT 
guaifenesin, phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76864-209
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76864-209-02	1 in 1 CARTON	06/03/2021
1		120 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 final	part341	06/03/2021

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