Label: BACZOL EXPECTORANT- guaifenesin, phenylephrine hcl syrup
- NDC Code(s): 76864-209-02
- Packager: Procaps S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 27, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
Product Labeling
NDC 76864-209-02
Baczol ®
EXPECTORANTGuaifenesin • Expectorant
Phenylephrine HCl • Nasal DecongestantFruit 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 syrupProduct 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 Drug M012 06/03/2021 Labeler - Procaps S.A. de C.V. (851259341)
