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

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BACZOLANTIGRIPAL (G)

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:

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

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

adults & children 12 years of age and older20mL every 4 hours, do not exceed 6 doses per 24 hours
children 6 to under 12 years of age10mL every 4 hours, do not exceed 5 doses per 24 hours
children under 6 years of agedo not use

Other information

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:76864-220
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE, (+/-)- (UNII: O2VT86KV7E) (PHENYLEPHRINE HYDROCHLORIDE, (+/-)- - UNII:O2VT86KV7E) PHENYLEPHRINE HYDROCHLORIDE, (+/-)-5 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76864-220-041 in 1 CARTON01/11/2023
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/11/2023
Labeler - Procaps S.A. de C.V. (851259341)

Revised: 2/2024
Document Id: 118174d5-d4a5-005e-e063-6394a90acd74
Set id: 118174d5-d4a4-005e-e063-6394a90acd74
Version: 1
Effective Time: 20240216
 
Procaps S.A. de C.V.