Baczol Cold (lex)

SPL v6

SPL

SPL Set ID 9d07b895-27ff-48b4-a597-29782a67a201

Route

ORAL

Published

Effective Date 2020-05-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (250 mg) Dextromethorphan (10 mg) Chlorpheniramine (4 mg) Phenylephrine

Inactive Ingredients

Fd&c Yellow No. 5 Glycerin Methylparaben Polyethylene Glycol 400 Propylparaben Water Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-05-25

Description

Drug Facts

Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and 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

Description

Drug Facts

Section 34088-5

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.

Section 42229-5

Drug Facts

Section 42232-9

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

Section 50565-1

Keep out of reach of children.

Section 50567-7

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.

Section 50568-5

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

Section 50570-1

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.

Section 51727-6

Section 53413-1

Questions or comments?

[email protected] 754-260-6479

Section 53414-9

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

Section 55105-1

Purpose

Acetaminophen .................... Analgesic and Antipyretic

Dextromethorphan HBr ....................Cough Suppressant

Chlorpheniramine Maleate .........................Antihistamine

Phenylephrine HCl ........................ Nasal Decongestant

Section 55106-9

Active ingredients (in each 5 mL tsp.)

Acetaminophen 250 mg

Dextromethorphan HBr 10 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Section 60561-8

Other information • Store at room temperature 15º-30ºC (59º-86ºF).

Tamper evident: Do not use if there is evidence of tampering.

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

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Section 34088-5 (34088-5)

Section 42229-5 (42229-5)

Drug Facts

Section 42232-9 (42232-9)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

Section 53413-1 (53413-1)

Questions or comments?

[email protected] 754-260-6479

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL tsp.)

Acetaminophen 250 mg

Dextromethorphan HBr 10 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Section 60561-8 (60561-8)

Other information • Store at room temperature 15º-30ºC (59º-86ºF).

Tamper evident: Do not use if there is evidence of tampering.

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "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.", "34068-7": "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", "34071-1": "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.", "34088-5": "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.", "42229-5": "Drug Facts", "42232-9": "Precaution : this product contains FD&C Yellow #5 (Tartrazine) as color additive.", "50565-1": "Keep out of reach of children.", "50567-7": "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.", "50568-5": "Ask a Doctor or pharmacist before use if you are taking the blood thinning drug warfarin.", "50570-1": "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.", "51727-6": "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.", "53413-1": "Questions or comments? customer.service@lablopez.com.sv 754-260-6479", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Acetaminophen .................... Analgesic and Antipyretic Dextromethorphan HBr ....................Cough Suppressant Chlorpheniramine Maleate .........................Antihistamine Phenylephrine HCl ........................ Nasal Decongestant", "55106-9": "Active ingredients (in each 5 mL tsp.) Acetaminophen 250 mg Dextromethorphan HBr 10 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg", "60561-8": "Other information • Store at room temperature 15º-30ºC (59º-86ºF). Tamper evident: Do not use if there is evidence of tampering.", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:05.903690 · Updated: 2026-03-14T23:06:25.914429