BACZOL EXPECTORANT- guaifenesin and phenylephrine hydrochloride liquid

Baczol Expectorant by

Drug Labeling and Warnings

Baczol Expectorant by is a Otc medication manufactured, distributed, or labeled by Lex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL tsp.)	Purpose
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal Decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves nasal congestion due to the common cold.

Warnings

• Do not exceed recommended dosage
• If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a Doctor.

Do not use this product

• for persistent 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 Monoaminooxidase 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 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 persist 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.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 information

• Store at room temperature 15°-30°C (59°-86°F).

Tamper evident

Do not use if there is evidence of tampering.

Inactive ingredients

Banana flavor, cherry flavor, citric acid, hidrogenated castor oil, magnesium aluminum silicate, methyl paraben (as preservative), propylene glycol, propyl paraben (as preservative), purified water, silicon dioxide, sorbitol, sucralose, titanium dioxide, vanillin flavor, xanthan gum.

Questions or comments?

1-888-795-4540

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Distributed in the USA by:
PLAZA IZALCO WHOLESALE
417, Clifford Avenue, Alexandria VA, 22305

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Carton

NDC: 49523-501-04

Baczol®

EXPECTORANT

Guaifenesin Expectorant
Phenylephrine HCl Nasal Decongestant

Fruit Flavor

• Sugar FREE
• Alcohol FREE

4 fl. oz.

Laboratorios López

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

INGREDIENTS AND APPEARANCE

BACZOL EXPECTORANT 
guaifenesin and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49523-501
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 HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
VANILLIN (UNII: CHI530446X)

Product Characteristics
Color		Score
Shape		Size
Flavor	BANANA, CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49523-501-04	1 in 1 CARTON
1		120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/04/2013

Labeler - Lex Inc (046172888)

Establishment
Name	Address	ID/FEI	Business Operations
Lex Inc		046172888	MANUFACTURE(49523-501)