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ANGINAC®-Cold& Flu

Product Composition

Manufacturer of Each uncoated tablet contains: Aceclofenac 100 mg Paracetamol 325 mg + Phenylepherine 5 mg + Cetirizine 10 mg + Caffeine 25 mg

Packaging Details

20 x 10 Blister

Product Description

ANGINAC Cold & Flu Tablets

Aceclofenac 100 mg + Paracetamol 325 mg + Phenylephrine HCl 5 mg + Cetirizine HCl 10 mg + Caffeine 25 mg

ANGINAC Cold & Flu is an uncoated tablet formulation shown on the artwork with five active ingredients intended to address pain, fever and selected cold/allergic nasal symptoms.

1. Product Information

Parameter	Details
Brand Name	ANGINAC Cold & Flu
Dosage Form	Uncoated Tablet
Route	Oral
Composition	Aceclofenac 100 mg + Paracetamol 325 mg + Phenylephrine HCl 5 mg + Cetirizine HCl 10 mg + Caffeine 25 mg
Therapeutic Category	Cold & Flu / Analgesic / Antihistamine / Decongestant
Pack Size	20 × 10 Tablets
Prescription	Rx, as shown on artwork
Colour	Sunset Yellow FCF

Composition

Each uncoated tablet contains:

Aceclofenac IP — 100 mg
Paracetamol IP — 325 mg
Phenylephrine Hydrochloride IP — 5 mg
Cetirizine Hydrochloride IP — 10 mg
Caffeine (Anhydrous) IP — 25 mg
Excipients — q.s.
Colour: Sunset Yellow FCF

2. Therapeutic Uses

The individual ingredients have roles in managing different symptoms:

Aceclofenac: pain and inflammation
Paracetamol: pain and fever
Phenylephrine: nasal congestion
Cetirizine: allergic nasal symptoms such as sneezing and runny nose
Caffeine: analgesic adjuvant/stimulant component

Combination products with these ingredients are marketed for symptomatic management of common-cold symptoms, including nasal congestion, runny nose, sneezing, headache and body ache.

Potential symptom areas

Headache associated with cold symptoms
Body ache
Fever
Nasal congestion
Runny nose
Sneezing
Allergy-associated nasal symptoms
Pain and inflammatory discomfort

Important: The specific approved indication for ANGINAC Cold & Flu should be confirmed against the product’s current regulatory approval and prescribing information.

3. Mechanism of Action

Aceclofenac 100 mg

Aceclofenac is an NSAID (non-steroidal anti-inflammatory drug).

It reduces the production of prostaglandin-related inflammatory mediators, thereby providing:

Analgesic action
Anti-inflammatory action
Reduction of pain associated with inflammation

It contributes primarily to the pain and inflammatory component of the formulation.

Paracetamol 325 mg

Paracetamol is an analgesic and antipyretic.

It acts predominantly through central mechanisms involved in pain and temperature regulation.

Main effects

Analgesic: Helps reduce pain.

Antipyretic: Helps reduce fever.

Together with aceclofenac, it provides two different analgesic components; however, concurrent analgesic exposure also increases the importance of appropriate prescribing.

Phenylephrine Hydrochloride 5 mg

Phenylephrine is an alpha-adrenergic sympathomimetic decongestant.

Its vasoconstrictive activity can reduce swelling of nasal mucosal tissues and is intended to help with nasal stuffiness.

Symptomatic role

Nasal mucosal congestion → reduced mucosal swelling → potential improvement in nasal airflow

However, the evidence surrounding the effectiveness of oral phenylephrine as a nasal decongestant has been questioned, and CDSCO’s FDC reviews have specifically raised this issue.

Cetirizine Hydrochloride 10 mg

Cetirizine is a second-generation H1 antihistamine.

It blocks the effects of histamine and can reduce allergy-associated symptoms such as:

Sneezing
Runny nose
Nasal irritation
Watery eyes

It therefore contributes primarily to the allergic/nasal symptom component.

Cetirizine can still cause drowsiness in some individuals, although it is generally less sedating than many first-generation antihistamines.

Caffeine 25 mg

Caffeine is included as an analgesic adjuvant in some analgesic formulations.

It may enhance analgesic effects in selected acute-pain situations and acts as a central nervous system stimulant.

The caffeine content should be considered together with dietary caffeine from coffee, tea, energy drinks and other sources.

4. Combined Action

The formulation is designed around several symptom targets:

Ingredient	Primary role
Aceclofenac 100 mg	Analgesic + anti-inflammatory
Paracetamol 325 mg	Analgesic + antipyretic
Phenylephrine 5 mg	Decongestant
Cetirizine 10 mg	Antihistamine
Caffeine 25 mg	Analgesic adjuvant

Overall formulation concept

Pain & inflammation
→ Aceclofenac

Pain & fever
→ Paracetamol

Nasal congestion
→ Phenylephrine

Sneezing/runny nose
→ Cetirizine

Analgesic adjuvant
→ Caffeine

5. Potential Benefits

✔ Pain relief

Aceclofenac and paracetamol provide analgesic activity.

✔ Anti-inflammatory action

Aceclofenac contributes anti-inflammatory activity.

✔ Fever reduction

Paracetamol provides antipyretic activity.

✔ Nasal symptom support

Phenylephrine provides the decongestant component.

✔ Allergy symptom support

Cetirizine helps control histamine-mediated symptoms such as sneezing and runny nose.

✔ Multi-symptom formulation

Several symptomatic components are combined into a single oral dosage form.

6. Common Clinical Symptom Applications

Symptom	Relevant component
Headache	Aceclofenac + Paracetamol
Body ache	Aceclofenac + Paracetamol
Fever	Paracetamol
Inflammatory pain	Aceclofenac
Nasal congestion	Phenylephrine
Sneezing	Cetirizine
Runny nose	Cetirizine
Cold-associated discomfort	Combination

7. Suggested Use & Dosage

The artwork provides the composition but does not specify a dosing schedule.

Therefore, the product page should state:

Take ANGINAC Cold & Flu Tablets only as directed by the physician.

Administration

Take orally with water.
Follow the prescribed dose and duration.
Do not exceed the prescribed dose.
Avoid taking additional medicines containing paracetamol or other NSAIDs unless advised by a healthcare professional.
Do not combine with another cold/flu product without checking its ingredients.

8. Important Safety Considerations

Because this formulation contains both aceclofenac and paracetamol, patients should avoid unnecessary duplication with other analgesic medicines.

Aceclofenac-related considerations

NSAIDs can cause:

Gastric irritation
Indigestion
Nausea
Abdominal discomfort
Gastritis
Ulceration or gastrointestinal bleeding
Kidney-related adverse effects
Fluid retention

Patients with a history of peptic ulcer, gastrointestinal bleeding, significant kidney disease, cardiovascular disease or NSAID hypersensitivity require medical assessment before use.

Paracetamol-related consideration

Excessive total paracetamol exposure can cause serious liver injury.

Avoid simultaneous use of multiple paracetamol-containing medicines unless specifically directed by a healthcare professional.

9. Cardiovascular Precautions

Phenylephrine may increase blood pressure or produce cardiovascular effects in susceptible individuals.

Medical advice is particularly important in patients with:

Hypertension
Heart disease
Arrhythmia
Hyperthyroidism
Other cardiovascular disorders

10. Drowsiness & Driving

Cetirizine may cause drowsiness in some patients.

Until individual sensitivity is known, patients should use caution with:

Driving
Operating machinery
Working at heights
Activities requiring full alertness

Alcohol may increase impairment.

11. Side Effects

Possible adverse effects may include:

Gastrointestinal

Nausea
Vomiting
Indigestion
Stomach discomfort
Heartburn

Nervous system

Dizziness
Headache
Drowsiness
Restlessness

Cardiovascular

Palpitations
Increased blood pressure

Other

Dry mouth
Skin rash
Allergic reactions

Serious symptoms such as gastrointestinal bleeding, severe allergic reaction, breathing difficulty, chest pain or significant liver/kidney symptoms require prompt medical attention.

12. Drug Interactions

Tell the doctor about all medicines being taken.

Particular attention should be given to:

Other NSAIDs
Other paracetamol-containing medicines
Anticoagulants/antiplatelet medicines
Corticosteroids
Medicines affecting kidney function
Antihypertensive medicines
Other decongestants
Sedative medicines
Other antihistamines
Caffeine-containing medicines/products
Alcohol

13. Pregnancy & Breastfeeding

Use during pregnancy or breastfeeding should be based on medical advice.

Because the product contains an NSAID, particular caution is required during pregnancy, especially in later pregnancy.

Patients who are pregnant, planning pregnancy or breastfeeding should inform their healthcare professional before using the product.

14. Use in Elderly Patients

Elderly patients may have increased susceptibility to:

Gastrointestinal adverse effects
Kidney impairment
Cardiovascular effects
Dizziness
Drug interactions

Appropriate medical supervision is recommended.

15. Liver & Kidney Impairment

Liver

Patients with liver disease should inform their doctor because the formulation contains paracetamol and aceclofenac.

Kidney

Patients with kidney disease or reduced kidney function should use the medicine only under medical supervision because NSAIDs can adversely affect renal function in susceptible patients.

16. When to Seek Immediate Medical Attention

Seek urgent medical attention for:

Difficulty breathing
Facial or throat swelling
Severe allergic reaction
Black/tarry stools
Vomiting blood
Severe abdominal pain
Chest pain
Severe palpitations
Markedly increased blood pressure
Yellowing of skin or eyes
Severe or unusual weakness
Accidental overdose

17. Storage

Store ANGINAC Cold & Flu Tablets:

In a cool, dry place.
Away from direct sunlight.
Away from excessive heat and moisture.
In the original packaging.
Out of reach of children.

Do not use after the expiry date.

18. Key Product Features