BACZOLANTIGRIPAL (G) (DA)

Drug Details [pdf]

BACZOL ANTIGRIPAL- acetaminophen, dextromethorphan, guaifenesin, phenylephrine liquid
Procaps S.A. de C.V.

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BACZOLANTIGRIPAL (G) (DA)

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.

Ask 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

Baczol Expectorant

BACZOL ANTIGRIPAL
acetaminophen, dextromethorphan, guaifenesin, phenylephrine liquid

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76864-220-04	1 in 1 CARTON	01/11/2023	01/01/2024
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	01/11/2023	01/01/2024

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

Revised: 12/2024

Document Id: 2a873f87-596e-9441-e063-6394a90a424c

Set id: 118174d5-d4a4-005e-e063-6394a90acd74

Version: 2

Effective Time: 20241230

Trademark Results [Baczol]

Mark Image Registration \| Serial	Company Trademark Application Date
BACZOL 87236823 5344510 Live/Registered	LABORATORIOS LOPEZ, S.A. DE C.V. 2016-11-15
BACZOL 77930773 3872527 Dead/Cancelled	LABORATORIOS LOPEZ, S.A. DE C.V. 2010-02-08
BACZOL 77894598 not registered Dead/Abandoned	HEIDBRINK GARED 2009-12-16

BACZOLANTIGRIPAL (G) (DA)

Baczol by

Drug Labeling and Warnings

Drug Details [pdf]

BACZOLANTIGRIPAL (G) (DA)

Drug Facts

Active ingredients & Purposes

Uses

Warnings

Do not use

Ask a doctor before use if the user has a

Ask a doctor or pharmacist before use if the user is

Ask a doctor before use if the user

When using this product

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

Trademark Results [Baczol]

BACZOLANTIGRIPAL (G) (DA)

Baczol by

Drug Labeling and Warnings

Drug Details [pdf]

BACZOLANTIGRIPAL (G) (DA)

Drug Facts

Active ingredients & Purposes

Uses

Warnings

Do not use

A​sk a doctor before use if the user has a

Ask a doctor or pharmacist before use if the user is

Ask a doctor before use if the user

When using this product

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

Trademark Results [Baczol]

Ask a doctor before use if the user has a