FDA Label for Baczol Antigripal

Otc - Purpose

Uses

Temporarily relieves common cold/flu symptoms:

• minor aches and pain
• sore throat
• headache
• stuffy nose
• nasal congestion
• cough due to minor throat and bronchial irritation
• and temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if  adults take more than

6 doses in 24 hours, which is the maximum daily amount

• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever,

headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.

A​Sk A Doctor Before Use If The User Has A

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• a cough that is accompanied by excessive
• phlegm (mucus)
• a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• trouble urinating due to an enlarged
• prostate gland

Ask A Doctor Or Pharmacist Before Use If The User Is

• taking the blood thinning drug warfarin

Ask A Doctor Before Use If The User

• is a child with pain of arthritis

When Using This Product

• do not exceed recommended dosage

Stop Use And Ask A Doctor If

• nervousness, dizziness, or sleeplessness occur
• redness or swelling is present
• pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
• fever gets worse or lasts more than 3 days
• any new symptoms occur
• a persistent cough or symptoms do not improve within 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• only use the dosing cup provided
• shake well before use
• if you are taking other cold/flu products, read complete labeling before dosing

adults & children 12 years of age and older	20mL every 4 hours, do not exceed 6 doses per 24 hours
children 6 to under 12 years of age	10mL every 4 hours, do not exceed 5 doses per 24 hours
children under 6 years of age	do not use

Other Information

• each 10 mL contains: sodium 10mg
• store between 68-77°F (20-25°C)
• do not refrigerate

DO NOT USE IF SAFETY SEAL UNDER CAP IMPRINTED WITH” SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSING.

Inactive Ingredients

citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, 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