BACZOL COLD MEDICINE- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate liquid

Baczol Cold Medicine by

Drug Labeling and Warnings

Baczol Cold Medicine by is a Otc medication manufactured, distributed, or labeled by Lex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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)