Baczol Cold Medicine description, usages, side effects, indications, overdosage, supplying and lots more!

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Baczol Cold Medicine

Lex Inc

Baczol Cold Medicine


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

Baczol Cold Medicine 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

Baczol Cold Medicine 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

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.

Baczol Cold Medicine

Baczol Cold Medicine

ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, and CHLORPHENIRAMINE MALEATE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49523-505
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 250 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
polyethylene glycol 400
METHYLPARABEN
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
PROPYLPARABEN
water
Sucralose
titanium dioxide
FD&C YELLOW NO. 5

Product Characteristics

Color
YELLOW

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 NDC:49523-505-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-02-04


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Be sure to consult your doctor before taking any medication!
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