BACZOL ANTIGRIPAL- acetaminophen, dextromethorphan, guaifenesin, phenylephrine liquid

Baczol by

Drug Labeling and Warnings

Baczol by is a Otc medication manufactured, distributed, or labeled by Procaps S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients & Purposes

• Active ingredients (in each 10 mL): Purposes
• Acetaminophen 325 mg ........: Pain reliever/ fever reducer
• Dextromethorphan HBr 10 mg ........: Cough suppressant
• Guaifenesin 200 mg........: Expectorant
• Phenylephrine HCL 5 mg ........: Nasal decongestant

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 customer.service@sofgenpharma.com

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

BACZOL  ANTIGRIPAL
acetaminophen, dextromethorphan, guaifenesin, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76864-220
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE, (+/-)- (UNII: O2VT86KV7E) (PHENYLEPHRINE HYDROCHLORIDE, (+/-)- - UNII:O2VT86KV7E)	PHENYLEPHRINE HYDROCHLORIDE, (+/-)-	5 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76864-220-04	1 in 1 CARTON	01/11/2023
1		118 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	01/11/2023

Labeler - Procaps S.A. de C.V. (851259341)