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Baczol Cold Medicine (Lex Inc)

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LIQUID 1 BOTTLE in 1 CARTON (49523-505-04) > 120 mL in 1 BOTTLE Label Information

Complete Baczol Cold Medicine Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL tsp.) Purpose
    Acetaminophen 250 mg Analgesic and Antipyretic
    Dextromethorphan HBr 10 mg Cough Suppressant
    Chlorpheniramine Maleate 4 mg Antihistamine
    Phenylephrine HCl 10 mg Nasal Decongestant

  • 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

    Liver warning

    This products 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.

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

    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.

    Precaution

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

    Do Not Use

    If you are not 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.

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

    Keep out of reach of children.

    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.


  • 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 information

    • Store at room temperature 15°-30°C (59°-86°F).

    Tamper evident

    Do not use if there is evidence of tampering.


  • Inactive ingredients

    Banana Flavor, cherry flavor, FD&C yellow #5, glycerin, polyethylene glycol 400, methyl paraben (as preservative), natrasol, propyl paraben (as preservative), purified water, sucralose and titanium dioxide.


  • Preguntas o comentarios / Questions or comments?

    1-888-795-4540


  • SPL UNCLASSIFIED SECTION

    Distributed in the USA by:
    PLAZA IZALCO WHOLESALE
    417, Clifford Avenue, Alexandria VA, 22305


  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    NDC 49523-505-04

    Baczol®

    COLD MEDICINE

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

    Fruit Flavor

    • Sugar FREE
    • Alcohol FREE

    4 fl. oz.

    Laboratorios López

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

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    BACZOL COLD MEDICINE 
    acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49523-505
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color YELLOW Score     
    Shape Size
    Flavor BANANA, CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49523-505-04 1 in 1 CARTON
    1 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/04/2013
    Labeler - Lex Inc (046172888)
    Establishment
    Name Address ID/FEI Business Operations
    Lex Inc 046172888 MANUFACTURE(49523-505)