Broncochem Expectorant Ii

Broncochem Expectorant Ii
SPL v1
SPL
SPL Set ID 1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a
Route
ORAL
Published
Effective Date 2025-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Saccharin Sodium Sodium Benzoate Sodium Chloride Ammonium Glycyrrhizate Disodium Hedta Citric Acid Monohydrate Sorbitol Propylene Glycol Acetic Acid Raspberry Fd&c Red No. 40 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-21

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 accompanied by excessive phlem (mucus).  Likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor.  A persistent cough may be a sing of a serious condition. Stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache.  As with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing Pseudoephedrine HCl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Use caution when driving a motor vehicle or operating machinery.

Purpose

Analgesic Antihistaminic Antotussive Expectorant Decongestant

Dosage and Administration

Do not exceed 6 doses in a 24 hour period Adults and chuildren 12 years and over: (10mL or cc) using metered dosage spoon every 4 hours. Children 6 years up to 12 years: (5mL or cc) using metered dosage spoon every 4 hours


Medication Information

Purpose

Analgesic

Antihistaminic

Antotussive

Expectorant

Decongestant

Dosage and Administration

Do not exceed 6 doses in a 24 hour period

Adults and chuildren 12 years and over: (10mL or cc) using metered dosage spoon every 4 hours.

Children 6 years up to 12 years: (5mL or cc) using metered dosage spoon every 4 hours

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 accompanied by excessive phlem (mucus).  Likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor.  A persistent cough may be a sing of a serious condition. Stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache.  As with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing Pseudoephedrine HCl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Use caution 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 accompanied by excessive phlem (mucus).  Likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor.  A persistent cough may be a sing of a serious condition. Stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache.  As with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing Pseudoephedrine HCl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Use caution when driving a motor vehicle or operating machinery.

Indications & Use

Bronchial congestion

Irritation of the respiratory passages

Nasal congestion

Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive

Antitussive

Temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis

Active Ingredients

Acetaminophen

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Iactive Ingredient

Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

Drug Interaction Precautions

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 2 weeks after stopping the MAOI drug.  If you are uncertain whether your presciption drug contains an MAOI, consult a health professional before taking this product

Keep Out of the Reach of Children

In case of accidental overdose, seek professional assistancve or contact a poison control center inmediately

Package Label Principal Display Panel


Structured Label Content

Purpose

Analgesic

Antihistaminic

Antotussive

Expectorant

Decongestant

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 accompanied by excessive phlem (mucus).  Likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor.  A persistent cough may be a sing of a serious condition. Stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache.  As with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing Pseudoephedrine HCl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Use caution when driving a motor vehicle or operating machinery.

Indications & Use

Bronchial congestion

Irritation of the respiratory passages

Nasal congestion

Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive

Antitussive

Temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis

Active Ingredients

Acetaminophen

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Iactive Ingredient

Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

Dosage and Administration

Do not exceed 6 doses in a 24 hour period

Adults and chuildren 12 years and over: (10mL or cc) using metered dosage spoon every 4 hours.

Children 6 years up to 12 years: (5mL or cc) using metered dosage spoon every 4 hours

Drug Interaction Precautions

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 2 weeks after stopping the MAOI drug.  If you are uncertain whether your presciption drug contains an MAOI, consult a health professional before taking this product

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

In case of accidental overdose, seek professional assistancve or contact a poison control center inmediately

Package Label Principal Display Panel


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