FDA Label for Baczol Expectorant
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENTS & PURPOSES
- OTC - PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE USER HAS A
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- MFG. FOR: & DIST BY:
- PRINCIPAL DISPLAY PANEL
Baczol Expectorant Product Label
The following document was submitted to the FDA by the labeler of this product Procaps S.a. De C.v.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Drug Facts
Active Ingredients & Purposes
Active ingredients (in each 5 mL tsp.)
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Otc - Purpose
Active ingredients (in each 10 mL) | Purposes |
Dextromethorphan HBr 10mg ......... | Cough suppressant |
Guaifenesin 200 mg....... | Expectorant |
Uses
Temporarily relieves common cold symptoms:
- cough due to minor throat & bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Do Not Use
- if you are now taking a prescription monoamine oxidase 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
ASk A Doctor Before Use If The User Has A
- cough that is accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
Stop Use And Ask A Doctor If
- cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
- only use the dosing cup provided
- do not exceed 6 doses in a 24-hour period
| Age | Dose |
| adults and children 12 years and older | 20mL every 4 hours |
| children 6 to 12 years | 10mL every 4 hours |
| children under 6 years | do not use |
Other Information
- each 10 mL contains: potassium 10mg, sodium 10mg
- store between 68-77°F (20-25°C)
- do not refrigerate
Inactive Ingredients
citric acid anhydrous, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum.
Questions Or Comments?
+1-754-260-6479 (M-F) 9 AM to 5 PM EST or [email protected]
Mfg. For: & Dist By:
Mfg. for/ Fdo. para:
PROCAPS GROUP
Boulevard de Ejercito Nacional, Km. 5 1/2, Soyapango,
San Salvador, El Salvador, C.A.
Baczol® is a registered trademark of Procaps S.A. De C.V.
Dist. by/ por:
Sofgen Pharmaceuticals LLC
21500 Biscayne Boulevard Ste. 600,
Aventura, FL 33180
* Please review the disclaimer below.