Baczol Expectorant (lex)

Baczol Expectorant (lex)
SPL v5
SPL
SPL Set ID 8e928b79-2178-47ef-8427-6bb57f143261
Route
ORAL
Published
Effective Date 2021-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-03

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

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

Dosage and 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

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

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

purified water, sodium citrate, sucralose, xanthan gum

Section 53413-1

Questions or Comments?

[email protected]

Section 53414-9

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

Section 55105-1

Purpose

Guaifenesin .....................Expectorant

Phenylephrine ........Nasal Decongestant

Section 55106-9

Active ingredients (in each 5 mL tsp.)

Guaifenesin 200 mg

Phenylephrine HCl  5 mg

Section 60561-8

Other information  • Store at room temperature 15º-30ºC (59º-86ºF).

Tamper evident: Do not use if there is evidence of tampering.

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


Structured Label Content

Indications and Usage (34067-9)

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

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

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

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

purified water, sodium citrate, sucralose, xanthan gum

Section 53413-1 (53413-1)

Questions or Comments?

[email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Guaifenesin .....................Expectorant

Phenylephrine ........Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL tsp.)

Guaifenesin 200 mg

Phenylephrine HCl  5 mg

Section 60561-8 (60561-8)

Other information  • Store at room temperature 15º-30ºC (59º-86ºF).

Tamper evident: Do not use if there is evidence of tampering.

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


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Raw Label Data

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