COFFMUL-DCG Tablets – Complete Product Information

1. Product Overview

COFFMUL-DCG Tablets by Amcare Pharmaceuticals are a combination cough and cold formulation containing Dextromethorphan Hydrobromide, Cetirizine Dihydrochloride, Phenylephrine Hydrochloride, Ambroxol Hydrochloride and Guaiphenesin.

According to the supplied product artwork, each uncoated tablet contains:

• Dextromethorphan Hydrobromide IP – 15 mg

• Cetirizine Dihydrochloride IP – 5 mg

• Phenylephrine Hydrochloride IP – 10 mg

• Ambroxol Hydrochloride IP – 30 mg

• Guaiphenesin IP – 100 mg

• Excipients – Q.S.

The formulation combines a cough suppressant, antihistamine, nasal decongestant, mucolytic and expectorant. Amcare’s published product page lists the same five active ingredients.

2. Product Composition

Product Details

Packaging verification: The supplied artwork shows 20 × 10 tablets, whereas Amcare’s published webpage currently lists a 30 × 10 blister pack. Confirm the correct marketed pack configuration before publishing.

3. What are COFFMUL-DCG Tablets?

COFFMUL-DCG Tablets contain five active ingredients with different pharmacological roles in managing selected respiratory symptoms.

Dextromethorphan Hydrobromide

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

Cetirizine Dihydrochloride

Cetirizine is an antihistamine that helps relieve allergy-related symptoms such as sneezing, runny nose and itching.

Phenylephrine Hydrochloride

Phenylephrine is intended to relieve nasal congestion by reducing swelling of blood vessels in the nasal passages.

Ambroxol Hydrochloride

Ambroxol is a mucolytic that helps reduce the viscosity of respiratory mucus, supporting its clearance.

Guaiphenesin

Guaiphenesin is an expectorant that helps thin mucus in the airways so that it can be coughed up more easily.

4. Active Ingredient Profile

A. Dextromethorphan Hydrobromide IP – 15 mg

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

Main role: Cough suppression

It acts on central pathways involved in coughing and may temporarily reduce:

• Irritating cough

• Dry or non-productive cough

• Cough associated with a common cold

• Repeated coughing associated with selected respiratory illnesses

Dextromethorphan does not cure an infection or necessarily shorten the underlying illness.

B. Cetirizine Dihydrochloride IP – 5 mg

Cetirizine is an antihistamine that blocks the action of histamine, a chemical involved in allergic symptoms.

Main role: Allergy symptom relief

It may help relieve:

• Sneezing

• Runny nose

• Nasal itching

• Itchy nose or throat

• Watery or itchy eyes associated with allergies

Cetirizine is generally less sedating than older antihistamines, but it can still cause sleepiness or tiredness.

C. Phenylephrine Hydrochloride IP – 10 mg

Phenylephrine is a sympathomimetic medicine used as a nasal decongestant.

Main role: Nasal decongestion

It is intended to help relieve:

• Stuffy nose

• Nasal congestion associated with selected cold symptoms

• Nasal stuffiness associated with certain allergic conditions

Phenylephrine acts on adrenergic receptors and reduces swelling in the nasal passages.

D. Ambroxol Hydrochloride IP – 30 mg

Ambroxol is a mucolytic medicine used for selected respiratory conditions involving thick or difficult-to-clear mucus.

Main role: Mucus thinning

Ambroxol helps decrease mucus viscosity, supporting transport and removal of respiratory secretions.

Potential roles include:

• Helping loosen thick mucus

• Supporting clearance of respiratory secretions

• Making phlegm easier to expectorate

• Supporting management of selected respiratory conditions associated with abnormal mucus

Rare serious allergic and skin reactions have been reported with ambroxol-containing medicines.

E. Guaiphenesin IP – 100 mg

Guaiphenesin is an expectorant used to help relieve chest congestion.

Main role: Expectorant / Mucus clearance

It helps thin mucus in the airways, making it easier to cough up and clear.

Potential roles include:

• Helping loosen thick respiratory mucus

• Supporting expectoration

• Facilitating clearance of respiratory secretions

• Relieving symptoms associated with chest congestion

Guaiphenesin provides symptomatic relief rather than treating the underlying cause of respiratory illness.

5. What are COFFMUL-DCG Tablets Used For?

Based on the ingredients, COFFMUL-DCG may be considered for selected respiratory symptoms when the combination is clinically appropriate and consistent with its approved indications.

Cough

Dextromethorphan provides temporary cough suppression.

Sneezing and Runny Nose

Cetirizine helps control histamine-mediated allergy symptoms.

Nasal Congestion

Phenylephrine provides the nasal decongestant component.

Thick Mucus and Chest Congestion

Ambroxol and Guaiphenesin support mucus thinning and clearance.

Selected Cold-Related Symptoms

The ingredients target different symptoms that may occur together during some respiratory conditions.

Important: These are ingredient-based pharmacological roles, not confirmation of every approved indication for COFFMUL-DCG. Because the combination contains both a cough suppressant and mucus-clearing medicines, it should not automatically be described as suitable for every type of cough.

6. How Do COFFMUL-DCG Tablets Work?

Each active ingredient has a different principal mechanism.

Dextromethorphan → Cough Suppression

Cough stimulus

↓

Dextromethorphan acts on central cough pathways

↓

Temporary reduction in the urge to cough

Cetirizine → Antihistamine Action

Histamine-mediated allergic symptoms

↓

Cetirizine blocks H1 histamine receptors

↓

Relief of sneezing, runny nose and itching

Phenylephrine → Nasal Decongestion

Swelling of blood vessels in the nasal passages

↓

Phenylephrine’s decongestant action

↓

Potential reduction in nasal stuffiness

Ambroxol → Mucolytic Action

Thick respiratory mucus

↓

Ambroxol reduces mucus viscosity

↓

Mucus becomes easier to clear

Guaiphenesin → Expectorant Action

Mucus in the airways

↓

Guaiphenesin helps thin secretions

↓

Mucus becomes easier to cough up

Combined Action

7. Product Highlights

Five-ingredient formulation: Contains Dextromethorphan, Cetirizine, Phenylephrine, Ambroxol and Guaiphenesin.

Cough-suppressant action: Dextromethorphan temporarily reduces the urge to cough.

8. Dry Cough vs. Productive Cough

Understanding the type of cough is important when evaluating a combination of cough suppression and mucus-clearing ingredients.

Dry or Non-productive Cough

A dry cough produces little or no mucus. Dextromethorphan may temporarily suppress coughing when clinically appropriate.

Productive or Wet Cough

A productive cough brings up mucus or phlegm. Ambroxol and Guaiphenesin help support mucus clearance.

COFFMUL-DCG

Because the product combines a cough suppressant with mucolytic and expectorant ingredients, it should not be promoted as suitable for every cough.

The type of cough, quantity of mucus, underlying diagnosis and approved product indication should be considered before treatment.

9. Dosage and Administration

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

The artwork specifies the strength per uncoated tablet but does not show a complete dosage schedule.

General administration guidance

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

• Follow the prescribed frequency and duration.

• Do not exceed the prescribed dose.

• Do not combine it with another cough or cold preparation without checking the ingredients.

• Do not assume the tablet is suitable for children merely because the same brand has liquid formulations.

• Seek medical advice if symptoms persist or worsen.

Do not infer a dosage schedule from the strength alone. The current product information must establish the correct dose, approved patient group and treatment duration.

10. Important Safety Information

Avoid Duplicate Ingredients

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

Check for:

• Dextromethorphan in another cough suppressant

• Cetirizine or another antihistamine in an allergy medicine

• Phenylephrine or another decongestant in a cold medicine

• Ambroxol or Guaiphenesin in another respiratory preparation

Combination products should be checked carefully to avoid duplicate doses.

Drowsiness

Cetirizine can cause sleepiness or tiredness in some people. Take care with driving or operating machinery if affected.

Cardiovascular Precautions

Phenylephrine requires caution in patients with hypertension, heart disease and certain other medical conditions.

Dextromethorphan Interactions

Dextromethorphan has important interactions with MAOIs and certain other medicines. Inform the healthcare professional about all medicines being taken before using the product.

11. Possible Side Effects

Potential adverse effects may arise from one or more ingredients.

Dextromethorphan-related effects

• Dizziness

• Drowsiness

• Nervousness

• Restlessness

• Nausea

• Vomiting

Cetirizine-related effects

• Sleepiness or tiredness

• Headache

• Dry mouth

• Dizziness

• Nausea

Phenylephrine-related effects

Potential effects include nervousness, dizziness, sleep disturbance and cardiovascular effects in susceptible patients.

Ambroxol-related effects

Potential effects include gastrointestinal discomfort, rash and hypersensitivity reactions. Rare serious skin reactions have been reported.

Guaiphenesin-related effects

Potential effects include nausea, vomiting and headache.

12. Precautions

Medical advice should be obtained before use in patients with:

• High blood pressure

• Heart disease

• Thyroid disorders

• Diabetes

• Kidney or liver impairment

• Glaucoma or difficulty passing urine

• Persistent or unexplained cough

• Known hypersensitivity to any ingredient

• Current or recent use of MAOIs

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

The complete contraindications and precautions should be checked against the current approved COFFMUL-DCG product information.

13. Drug Interaction Considerations

Monoamine Oxidase Inhibitors (MAOIs)

Dextromethorphan and phenylephrine have important MAOI-related interaction warnings. Their use with MAOIs must follow the specific prescribing instructions and required washout periods.

Other Antidepressants

Some medicines affecting serotonin may interact with dextromethorphan. Professional review is important before combining treatments.

Other Antihistamines

Combining cetirizine with another antihistamine may increase unwanted effects such as drowsiness.

Other Decongestants

Combining phenylephrine with another sympathomimetic decongestant may increase adverse-effect risks.

Other Cough and Cold Medicines

Check ingredient lists carefully to prevent duplication of active ingredients.

14. Use in Children

The supplied artwork identifies COFFMUL-DCG as an uncoated tablet and does not specify an approved minimum age or paediatric dosage schedule.

India’s Ministry of Health and Family Welfare issued an advisory on 3 October 2025 stating that cough and cold medicines should not be prescribed or dispensed to children under two years and are generally not recommended for children below five years. Use in older children should follow careful clinical evaluation, close supervision and appropriate dosing.

Before publishing paediatric-use claims, verify:

• The approved minimum age

• The authorised indications

• The appropriate dose and frequency

• Product-specific contraindications and warnings

Do not describe COFFMUL-DCG Tablets as suitable for all children or infants without supporting approved product information.

15. When to Consult a Doctor

Medical evaluation is recommended if a cough:

• Persists or gets worse

• Is associated with difficulty breathing

• Is accompanied by chest pain

• Produces blood

• Occurs with persistent or high fever

• Is associated with significant wheezing

• Causes marked weakness or other concerning symptoms

Severe breathing difficulty, suspected overdose or a serious allergic reaction requires urgent medical attention.

16. Storage and Handling

Store COFFMUL-DCG according to the conditions stated on the approved product label.

General precautions include:

• Keep the tablets in their original blister until use.

• Protect the pack from excessive heat and moisture.

• Keep out of reach of children.

• Check the expiry date before use.

• Do not use damaged or visibly altered tablets.

• Follow the manufacturer’s storage instructions.

The precise storage temperature and shelf life should be confirmed from the approved product information.

17. Packaging Information

The supplied artwork shows:

• White carton with green, pink and yellow design elements

• COFFMUL-DCG Tablets branding

• Amcare Pharmaceuticals logo

• Blister-packed uncoated tablets

• The pack quantity 20 × 10 Tablets on the carton

However, Amcare’s published product page lists 30 × 10 Blister for the same tablet formulation. Confirm the actual approved marketed pack configuration before updating the website or printing promotional material.