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Drug Facts
Baczol Expectorant Syrup
FDA Label NDC 76864-209
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Procaps S.a. De C.v. for the product Baczol Expectorant (NDC 76864-209). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients (in each 5 mL tsp.)
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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 15°-30°C (59°-86°F).
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
Otc - Questions
Questions or Comments?
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
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