Label: BACZOL ANTIGRIPAL- acetaminophen, dextromethorphan, guaifenesin, phenylephrine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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  • 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 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

    • 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

  • INGREDIENTS AND APPEARANCE
    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)
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