Broncochem Maximum Cough Night 

Broncochem Maximum Cough Night 
SPL v3
SPL
SPL Set ID 1a3ed214-e09b-4266-b68b-39e7c3127d26
Route
ORAL
Published
Effective Date 2024-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Pyrilamine (6 mg)
Inactive Ingredients
Sugarcane Sodium Benzoate Fd&c Yellow No. 5 Orange Oil Methylparaben Sodium Propylparaben Sodium Alcohol 95% Sorbitol Solution 70% Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-09

Description

The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately.  Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping. 

Purpose

Antitussive Antihistamine

Dosage and Administration

Do not exceed 4 doses in a 24 hour period. Adult and children 12 years and older: (5 or 10 mL) 3 times a day. Children between 6 to 12 years old: (2.5 mL) 3 times a day.


Medication Information

Purpose

Antitussive Antihistamine

Dosage and Administration

Do not exceed 4 doses in a 24 hour period.

Adult and children 12 years and older: (5 or 10 mL) 3 times a day.

Children between 6 to 12 years old: (2.5 mL) 3 times a day.

Description

The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately.  Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping. 

Uses

Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.

Do Not Use

Stop using this medicine and contact your doctor right away if any of these unlikely but serious side effects occur, fast and irregular heartbeat, mental mood changes such as confusion, hallucinations, nervousness, seizures, tremor, problems with to pee.

If you are taking any monoamine oxidase inhibitor (MAOI), or two weeks after stopping them (certain medications for depression or psycological conditions may contain them).  If you are not sure if your prescription contains an MAOI, coinsult a professional of health before taking this product.

Warnings 

The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately.  Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping. 

Inactive Ingredient

Sugar, Sodium Benzoate, FD&C Yellow #5, Orange flavor, MEthyl  paraben, Propyl paraben, ethyl alcohol 95%, Sorbitol 70%, Purified water.

Otc Purpose Section

Antitussive

Antihistamine

Ask A Doctor/pharmacist 

Ask a doctor before use if yoy have

Liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland, cough that occurs with too much phlegm (mucus), presistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop Use and Ask A Doctor If

Symptoms last more than 7 days, symptoms worsen or come back, you develop a headache that wont go away, fever, or skin rash.  If pregnant or breast-feeding ask a health professional before use.

Otc Active Ingredient Section

Dextromethorphan HBr

Mepyramine maleate

Keep Out of the Reach of Children 

In case of accidental overdose, seek professional help or go to poison control center immediately.

Package Label Principal Display Panel


Structured Label Content

Uses

Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.

Do Not Use

Stop using this medicine and contact your doctor right away if any of these unlikely but serious side effects occur, fast and irregular heartbeat, mental mood changes such as confusion, hallucinations, nervousness, seizures, tremor, problems with to pee.

If you are taking any monoamine oxidase inhibitor (MAOI), or two weeks after stopping them (certain medications for depression or psycological conditions may contain them).  If you are not sure if your prescription contains an MAOI, coinsult a professional of health before taking this product.

Warnings 

The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately.  Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping. 

Inactive Ingredient

Sugar, Sodium Benzoate, FD&C Yellow #5, Orange flavor, MEthyl  paraben, Propyl paraben, ethyl alcohol 95%, Sorbitol 70%, Purified water.

Otc Purpose Section (OTC-PURPOSE SECTION)

Antitussive

Antihistamine

Ask A Doctor/pharmacist  (Ask a doctor/pharmacist )

Ask a doctor before use if yoy have

Liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland, cough that occurs with too much phlegm (mucus), presistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Dosage and Administration

Do not exceed 4 doses in a 24 hour period.

Adult and children 12 years and older: (5 or 10 mL) 3 times a day.

Children between 6 to 12 years old: (2.5 mL) 3 times a day.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Symptoms last more than 7 days, symptoms worsen or come back, you develop a headache that wont go away, fever, or skin rash.  If pregnant or breast-feeding ask a health professional before use.

Otc Active Ingredient Section (OTC - Active Ingredient Section)

Dextromethorphan HBr

Mepyramine maleate

Keep Out of the Reach of Children 

In case of accidental overdose, seek professional help or go to poison control center immediately.

Package Label Principal Display Panel (PACKAGE LABEL PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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