COFFMUL Softgel Capsules – Complete Product Information

1. Product Overview

COFFMUL Softgel Capsules by Amcare Pharmaceuticals are a combination cough and cold formulation containing Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride and Chlorpheniramine Maleate.

According to the supplied product artwork, each soft gelatin capsule contains:

• Dextromethorphan Hydrobromide IP – 10 mg

• Phenylephrine Hydrochloride IP – 5 mg

• Chlorpheniramine Maleate IP – 2 mg

• Excipients – Q.S.

The combination contains three ingredients with different pharmacological actions: a cough suppressant, a nasal decongestant and an antihistamine. It may provide symptomatic relief for selected cough, nasal congestion and allergy-related symptoms when clinically appropriate. Amcare’s published product page confirms the same composition and a packaging configuration of 10 × 1 × 10 blister capsules.

2. Product Composition

Product Details

3. What are COFFMUL Softgel Capsules?

COFFMUL Softgel Capsules combine three active ingredients to address different symptoms associated with selected upper-respiratory conditions.

Dextromethorphan Hydrobromide

Dextromethorphan is an antitussive that temporarily reduces the urge to cough by decreasing activity in the brain pathways involved in the cough reflex. It relieves symptoms rather than treating the underlying cause of the cough.

Phenylephrine Hydrochloride

Phenylephrine is a sympathomimetic ingredient used as a nasal decongestant. It is intended to help relieve nasal stuffiness associated with selected respiratory conditions.

Chlorpheniramine Maleate

Chlorpheniramine is a first-generation antihistamine that helps relieve histamine-mediated symptoms, including sneezing and runny nose. It may cause drowsiness and other antihistamine-related effects.

4. Active Ingredient Profile

A. Dextromethorphan Hydrobromide IP – 10 mg per capsule

Dextromethorphan is a non-opioid antitussive used for temporary relief of certain types of cough.

Main role: Cough suppression

It may temporarily help relieve:

• Irritating cough

• Dry or non-productive cough

• Cough associated with a common cold

• Repeated coughing associated with minor respiratory irritation

Dextromethorphan acts on central pathways involved in coughing. It does not cure an infection or necessarily shorten the duration of the underlying illness.

B. Phenylephrine Hydrochloride IP – 5 mg per capsule

Phenylephrine is a sympathomimetic ingredient used for nasal decongestion.

Main role: Nasal decongestion

Its intended symptom-relief role includes:

• Nasal stuffiness

• Nasal congestion

• Congestion associated with selected cold symptoms

Phenylephrine acts on adrenergic receptors and can cause vasoconstriction in the nasal mucosa.

C. Chlorpheniramine Maleate IP – 2 mg per capsule

Chlorpheniramine is a first-generation H1 antihistamine.

Main role: Allergy symptom relief

It may help relieve:

• Sneezing

• Runny nose

• Nasal itching

• Itchy nose or throat

• Watery or itchy eyes associated with allergy

It works by blocking histamine, a chemical involved in allergic symptoms.

5. What are COFFMUL Softgel Capsules Used For?

Based on the pharmacological actions of the ingredients, COFFMUL may be considered for selected cough and cold symptoms when the combination is clinically appropriate and consistent with its approved indications.

Cough

Dextromethorphan provides temporary cough suppression.

Nasal Congestion

Phenylephrine provides the nasal decongestant component.

Sneezing and Runny Nose

Chlorpheniramine helps relieve histamine-mediated symptoms.

Selected Cold-Related Symptoms

The combination may be considered when cough occurs together with nasal congestion or relevant allergy symptoms. Amcare’s published product information describes COFFMUL as a combination intended for symptomatic cough and cold relief.

6. How Do COFFMUL Softgel Capsules Work?

The three ingredients act through different mechanisms.

Dextromethorphan → Cough Suppression

Cough stimulus

↓

Dextromethorphan acts on central cough pathways

↓

Temporary reduction in the urge to cough

Phenylephrine → Nasal Decongestion

Nasal mucosal swelling

↓

Phenylephrine’s decongestant action

↓

Potential reduction in nasal stuffiness

Chlorpheniramine → Antihistamine Action

Histamine-mediated allergic symptoms

↓

Chlorpheniramine blocks H1 histamine receptors

↓

Relief of sneezing, runny nose and itching

Combined Action

In simple terms:

• Dextromethorphan → Cough suppression

• Phenylephrine → Nasal decongestion

• Chlorpheniramine → Allergy symptom relief

7. Product Highlights

1. Three-ingredient formulation

Contains Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride and Chlorpheniramine Maleate.

2. Cough-suppressant action

Dextromethorphan temporarily reduces the urge to cough.

3. Decongestant action

Phenylephrine provides the nasal decongestant component.

4. Antihistamine action

Chlorpheniramine helps relieve selected allergy-related symptoms.

5. Soft gelatin capsule formulation

The product is presented as soft gelatin capsules, as shown on the supplied artwork and Amcare’s product listing.

6. Blister packaging

Amcare lists the packaging configuration as 10 × 1 × 10 blister capsules.

8. Dry Cough vs. Productive Cough

Understanding the type of cough helps determine whether cough suppression is appropriate.

Dry or Non-productive Cough

A dry cough produces little or no mucus. Dextromethorphan may be used for temporary cough suppression when appropriate.

Productive or Wet Cough

A productive cough brings up mucus or phlegm. Coughing helps clear respiratory secretions, so suppressing it may not always be appropriate.

COFFMUL Softgel Capsules

The ingredient profile is most relevant to selected cough and cold symptoms where cough suppression, nasal decongestion and antihistamine action are all appropriate.

Website positioning recommendation: Avoid claiming that COFFMUL is suitable for every type of cough. Its use depends on the patient’s symptoms and the approved product information.

9. Dosage and Administration

The appropriate dose and duration of COFFMUL must be determined from the approved product information and healthcare professional’s instructions.

The supplied artwork gives the strength per capsule but does not establish a complete dosing schedule.

General administration guidance

• Take the capsule by mouth according to the prescription or approved label.

• Swallow the softgel whole with water unless the official product instructions specify otherwise.

• Do not cut, crush or open the capsule unless a healthcare professional confirms that this is appropriate.

• Do not exceed the prescribed dose.

• Do not combine with another cough or cold product without checking its ingredients.

• Seek medical advice if symptoms persist or worsen.

Do not infer a dose schedule from the capsule strength alone. The approved indications, dosage frequency, treatment duration and patient suitability must be confirmed from the current product information.

10. Important Safety Information

Avoid Duplicate Ingredients

Other cough, cold and allergy medicines may contain overlapping ingredients.

Check for:

• Dextromethorphan in another cough suppressant

• Phenylephrine or another decongestant in a cold medicine

• Chlorpheniramine or another antihistamine in an allergy medicine

Combining products with the same active ingredients can cause accidental overdosing.

Drowsiness

Chlorpheniramine may cause sleepiness or reduced alertness. Avoid driving or operating machinery if affected.

Cardiovascular Precautions

Phenylephrine requires caution in patients with high blood pressure, heart disease, diabetes and certain thyroid disorders.

Dextromethorphan Interactions

Dextromethorphan can interact with MAOIs and certain other medicines. Tell the healthcare professional about all prescription medicines, OTC products and supplements being used.

11. Possible Side Effects

Potential adverse effects may arise from one or more ingredients.

Dextromethorphan-related effects

Possible effects include:

• Dizziness

• Drowsiness

• Nervousness

• Restlessness

• Nausea

• Vomiting

Chlorpheniramine-related effects

Possible effects include:

• Drowsiness

• Dry mouth

• Dizziness

• Blurred vision

• Gastrointestinal discomfort

Phenylephrine-related effects

Possible effects can include:

• Nervousness

• Dizziness

• Sleep disturbance

• Increased blood pressure or other cardiovascular effects in susceptible patients

12. Precautions

Medical advice should be obtained before use in patients with:

• High blood pressure

• Heart disease

• Thyroid disorders

• Diabetes

• Glaucoma

• Difficulty passing urine

• Chronic respiratory disease

• Persistent or unexplained cough

• Known hypersensitivity to any ingredient

• Current or recent treatment with MAOIs

• Use of other sedating or cough-and-cold medicines

The exact contraindications and precautions must be confirmed from the current COFFMUL package insert.