Label: BACZOL COLD MEDICINE- acetaminophen, dextromethorphan hbr, chlorpheniramine maleate, phenylephrine hcl syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 28, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL tsp.)
    Acetaminophen 250 mg
    Dextromethorphan HBr 10 mg
    Chlorpheniramine Maleate 4 mg
    Phenylephrine HCl 10 mg

  • PURPOSE

    Purpose
    Acetaminophen .................... Analgesic and Antipyretic
    Dextromethorphan HBr ....................Cough Suppressant
    Chlorpheniramine Maleate .........................Antihistamine
    Phenylephrine HCl ........................ Nasal Decongestant

  • INDICATIONS & USAGE

    Uses • Temporarily relieves runny nose, sneezing, itching of
    the nose or throat, and itchy, watery eyes due to hay fever • nasal
    congestion due to the common cold • Calms the cough control
    center and relieves coughing • minor aches and pains associated
    with the common cold • temporarily reduces fever.

  • WARNINGS

    Warnings: Liver warning: This product contains
    acetaminophen
    • Severe liver damage may occur if • adult takes more than 6
    doses in 24 hours, which is the maximum daily amount •child
    takes more than 6 doses in 24 hours • taken with other drugs
    containing acetaminophen• adult has 3 or more alcoholic drinks
    every day while using this product • Do not give to children
    under 3 years of age or use for more than 10 days unless directed by
    a physician.

  • SPL UNCLASSIFIED SECTION

    Stop Use and ask a Doctor if • you have liver disease • pain, cough 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 • redness or swelling is present • new symptoms occur • you have a breathing
    problem such as emphysema or chronic bronchitis • you have glaucoma or difficulty in urination
    due to enlargement of the prostate gland • you have shortness of breath, asthma, heart disease,
    high blood pressure, thyroid disease, diabetes.

  • ASK DOCTOR/PHARMACIST

    Ask a Doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

  • WHEN USING

    When using this product, do not exceed recommended dosage. If nervousness, dizziness,
    or sleeplessness occur, discontinue use and consult a doctor. May cause excitability especially
    in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the
    drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving
    motor vehicle or operating machinery.

  • PRECAUTIONS

    Precaution: this product contains FD&C Yellow #5 (Tartrazine) as color additive.

  • DO NOT USE

    Do Not Use: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 • 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 allergic to acetaminophen or any of the
    inactive ingredients in the product • for persistent or chronic cough such as occurs with smoking,
    asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless
    directed by a doctor • if you are taking sedatives or tranquilizers, without first consulting your
    doctor.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose Warning: taking more than recommended
    dose (overdose) may cause liver damage. In case of accidental overdose,
    contact a physician or 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.

  • DOSAGE & ADMINISTRATION

    Directions  Do not exceed more than 6 doses for children and adults
    in a 24 - hour period.

    Adults and Children 12 years
    of age and over
     1 teaspoon (5 mL) every 4 hours
    Children 6 to under 12 years of age 1/2 teaspoon (2.5 mL) every 4 hours
    Children under 6 years of age Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information • Store at room temperature 15º-30ºC (59º-86ºF).
    Tamper evident: Do not use if there is evidence of tampering.

  • INACTIVE INGREDIENT

  • INACTIVE INGREDIENT

    Inactive ingredients Banana Flavor, cherry flavor, FD&C
    yellow #5, glycerin, methyl paraben (as preservative),
    polyethylene glycol 400, propyl paraben (as preservative),
    purified water, sucralose and Xanthan gum.

  • QUESTIONS

    Questions or comments?
    customer.service@lablopez.com.sv    754-260-6479

  • Product Labeling

    NDC 76864-208-01

    Baczol ®
    COLD MEDICINE

    Acetaminophen • Analgesic and Antipyretic
    Dextromethorphan HBr • Cough Suppressant
    Chlorpheniramine Maleate • Antihistamine
    Phenylephrine HCl • Nasal Decongestant

    Fruit Flavor

    For sale in the
    US only.

    SHAKE WELL
    BEFORE USE

    • Sugar FREE • Alcohol FREE

    4 fl.oz. (120 mL)

    Manufactured For: Laboratorios López, S.A. de C.V.
    Boulevard del Ejército Nacional, Km. 5 1/2,
    Soyapango, San Salvador, El Salvador, C.A.

    Baczol ® is registered trademark of Laboratorios López, S.A. de C.V.

    7  69041 04544  8

    Lot:                                                                                                    Rev. 05/2020

    Exp. Date:

    Baczol Bottle

    Baczol Carton 1

    res

  • INGREDIENTS AND APPEARANCE
    BACZOL COLD MEDICINE 
    acetaminophen, dextromethorphan hbr, chlorpheniramine maleate, phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76864-208
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorBANANA (BANANA, CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76864-208-011 in 1 CARTON05/25/2020
    1120 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 finalpart34105/25/2020
    Labeler - Procaps S.A. de C.V. (851259341)