Broncochem Cold & Flu Caplets

Broncochem Cold & Flu Caplets
SPL v4
SPL
SPL Set ID ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6
Route
ORAL
Published
Effective Date 2024-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (30 mg) Phenylephrine (5 mg) Chlorpheniramine (3 mg)
Inactive Ingredients
Cellulose, Microcrystalline Starch, Pregelatinized Corn Silicon Dioxide Magnesium Stearate Peg-80 Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-01-01

Description

Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with, smoking, asthma, chronic bronchitis, emphysema, or if cough is accompained by excessive phlem (mucus).  Likewise if you have heart disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, do not take this product unless directed by a physician. If nervousness, dizziness, or sleeplessness occurs, discontinue use or consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. A persistent cough may be a sign of a serius condition.  If cough or other symptoms persist or not improve with any drug, if you are pregnant or nursing a baby, seeh the advice of a health professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing pseudoephedryne HCl, or if you are taking this product precaution must be taken when driving a motor vehicle or operating machinery.

Indications and Usage

Bronchial congestion, irritation of the respiratory passages, nasal congestion. Antitussive, temporary reliev of allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergy rhinitis

Purpose

Analgesic Antihistaminic Antitussive Descongestant

Drug Interactions

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI), (Certain drugs for depression, psychiatric or emotional conditions, or Parkinsons disease) or for 2 weeks after stopping that MAOI drug, if you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product


Medication Information

Indications and Usage

Bronchial congestion, irritation of the respiratory passages, nasal congestion.

Antitussive, temporary reliev of allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergy rhinitis

Purpose

Analgesic

Antihistaminic

Antitussive

Descongestant

Drug Interactions

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI), (Certain drugs for depression, psychiatric or emotional conditions, or Parkinsons disease) or for 2 weeks after stopping that MAOI drug, if you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product

Description

Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with, smoking, asthma, chronic bronchitis, emphysema, or if cough is accompained by excessive phlem (mucus).  Likewise if you have heart disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, do not take this product unless directed by a physician. If nervousness, dizziness, or sleeplessness occurs, discontinue use or consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. A persistent cough may be a sign of a serius condition.  If cough or other symptoms persist or not improve with any drug, if you are pregnant or nursing a baby, seeh the advice of a health professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing pseudoephedryne HCl, or if you are taking this product precaution must be taken when driving a motor vehicle or operating machinery.

Warnings

Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with, smoking, asthma, chronic bronchitis, emphysema, or if cough is accompained by excessive phlem (mucus).  Likewise if you have heart disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, do not take this product unless directed by a physician.

If nervousness, dizziness, or sleeplessness occurs, discontinue use or consult a doctor.

If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

A persistent cough may be a sign of a serius condition.  If cough or other symptoms persist or not improve with any drug, if you are pregnant or nursing a baby, seeh the advice of a health professional before using this product.

Unless directed by a doctor, do not take this product if you are presently taking another product containing pseudoephedryne HCl, or if you are taking this product precaution must be taken when driving a motor vehicle or operating machinery.

Active Ingredients

Acetaminofen

Dextromethorphan HBr

Phenylephryne HCL

Chlorpheniramine Maleate

Inactive Ingredients

Cellulose Microcrystalline, Colloidal Silicon dioxide, Green Opadry, Magnesium Stearate, Pregelatinized Starch, PEG 4000

Keep Out of the Reach of Children

In case of accidental overdose, seek professional assistance or contact a poison control center immediately

Package Label Principal Display Panel


Structured Label Content

Purpose

Analgesic

Antihistaminic

Antitussive

Descongestant

Warnings

Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with, smoking, asthma, chronic bronchitis, emphysema, or if cough is accompained by excessive phlem (mucus).  Likewise if you have heart disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, do not take this product unless directed by a physician.

If nervousness, dizziness, or sleeplessness occurs, discontinue use or consult a doctor.

If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

A persistent cough may be a sign of a serius condition.  If cough or other symptoms persist or not improve with any drug, if you are pregnant or nursing a baby, seeh the advice of a health professional before using this product.

Unless directed by a doctor, do not take this product if you are presently taking another product containing pseudoephedryne HCl, or if you are taking this product precaution must be taken when driving a motor vehicle or operating machinery.

Drug Interactions

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI), (Certain drugs for depression, psychiatric or emotional conditions, or Parkinsons disease) or for 2 weeks after stopping that MAOI drug, if you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product

Active Ingredients

Acetaminofen

Dextromethorphan HBr

Phenylephryne HCL

Chlorpheniramine Maleate

Inactive Ingredients

Cellulose Microcrystalline, Colloidal Silicon dioxide, Green Opadry, Magnesium Stearate, Pregelatinized Starch, PEG 4000

Indications and Usage

Bronchial congestion, irritation of the respiratory passages, nasal congestion.

Antitussive, temporary reliev of allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergy rhinitis

Keep Out of the Reach of Children (Keep Out Of The Reach Of Children)

In case of accidental overdose, seek professional assistance or contact a poison control center immediately

Package Label Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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