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

BACZOL COLD MEDICINE by

Drug Labeling and Warnings

BACZOL COLD MEDICINE by is a Otc medication manufactured, distributed, or labeled by Procaps S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 yearsof 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:

res

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76864-208
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
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score
Shape		Size
Flavor	BANANA (BANANA, CHERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76864-208-01	1 in 1 CARTON	05/25/2020
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/25/2020

Labeler - Laboratorios Lopez S.A. de C.V. (851259341)

Registrant - Laboratorios Lopez S.A. de C.V. (851259341)