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Temperate®CPP

Product Composition

Manufacturer of Each uncoated tablet contains: Paracetamol 500 mg + Phenylepherine 10 mg + CPM 4 mg + Caffeine 30 mg

Packaging Details

10 x10 Blister

Product Description

TEMPERATE-CPP Tablets

Paracetamol 500 mg + Phenylephrine HCl 10 mg + Chlorpheniramine Maleate 4 mg + Caffeine 30 mg

TEMPERATE-CPP Tablets are an oral four-ingredient cold and flu formulation shown on the supplied artwork. Each tablet contains Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg, Chlorpheniramine Maleate 4 mg and Caffeine (Anhydrous) 30 mg.

The formulation is intended to address multiple symptoms such as pain, fever, nasal congestion, runny nose and sneezing.

1. Product Information

Parameter	Details
Brand Name	TEMPERATE-CPP
Dosage Form	Tablet
Route	Oral
Composition	Paracetamol 500 mg + Phenylephrine HCl 10 mg + Chlorpheniramine Maleate 4 mg + Caffeine 30 mg
Therapeutic Category	Cold & Flu / Analgesic / Antipyretic / Antihistamine / Decongestant
Pack Size	10 × 10 Tablets
Prescription Status	Rx, as shown on artwork

Composition

Each tablet contains:

Paracetamol — 500 mg
Phenylephrine Hydrochloride — 10 mg
Chlorpheniramine Maleate — 4 mg
Caffeine (Anhydrous) — 30 mg
Excipients — q.s.

2. What is TEMPERATE-CPP Used For?

TEMPERATE-CPP is designed as a multi-symptom cold and flu formulation.

Its individual ingredients provide different symptomatic roles:

Paracetamol → pain and fever
Phenylephrine → nasal decongestant component
Chlorpheniramine → antihistamine component for runny nose and sneezing
Caffeine → analgesic-adjuvant component

Depending on the patient’s symptoms and physician assessment, the formulation may be considered for:

Headache associated with cold symptoms
Fever
Body ache
Runny nose
Sneezing
Nasal congestion
Cold-associated discomfort
Flu-like symptoms

Important: The exact approved indication for the specific marketed product should be confirmed against its current regulatory approval and prescribing information.

3. Mechanism of Action

A. Paracetamol 500 mg

Paracetamol is an analgesic and antipyretic.

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

Analgesic action

Helps reduce the perception of mild-to-moderate pain.

Antipyretic action

Helps lower elevated body temperature associated with fever.

Therefore, paracetamol primarily addresses:

Headache + Body Ache + Fever

4. Phenylephrine Hydrochloride 10 mg

Phenylephrine is an alpha-adrenergic sympathomimetic used as a decongestant component.

Its vasoconstrictive action can reduce swelling of nasal mucosal tissues and may help relieve nasal stuffiness.

Symptomatic role

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

However, evidence concerning the effectiveness of oral phenylephrine as a nasal decongestant has been questioned in regulatory reviews. Therefore, website claims should avoid statements such as “guaranteed congestion relief” or “instant decongestion.”

5. Chlorpheniramine Maleate 4 mg

Chlorpheniramine is a first-generation H1 antihistamine.

It reduces the effects of histamine and can help control:

Sneezing
Runny nose
Watery eyes
Nasal irritation
Allergy-associated symptoms

Because chlorpheniramine can produce central nervous system effects, drowsiness and reduced alertness may occur.

6. Caffeine (Anhydrous) 30 mg

Caffeine is included as an analgesic-adjuvant component.

It may enhance the analgesic response of certain analgesics in some acute-pain situations.

The formulation contains 30 mg caffeine per tablet, so patients should also consider caffeine obtained from:

Tea
Coffee
Energy drinks
Cola
Other caffeinated products

Excessive caffeine intake may contribute to nervousness, insomnia or palpitations.

7. Combined Action

Ingredient	Primary role
Paracetamol 500 mg	Analgesic + antipyretic
Phenylephrine HCl 10 mg	Decongestant component
Chlorpheniramine Maleate 4 mg	Antihistamine
Caffeine 30 mg	Analgesic adjuvant

Overall formulation concept

Pain & Fever
↓
Paracetamol

Nasal Congestion
↓
Phenylephrine

Runny Nose & Sneezing
↓
Chlorpheniramine

Analgesic Adjuvant
↓
Caffeine

This creates a multi-symptom approach for selected cold and flu presentations.

8. Potential Therapeutic Benefits

✔ Pain relief

Paracetamol provides the principal analgesic effect.

✔ Fever reduction

Paracetamol provides antipyretic activity.

✔ Nasal symptom support

Phenylephrine provides the decongestant component.

✔ Runny nose and sneezing

Chlorpheniramine provides antihistamine activity.

✔ Analgesic adjuvant

Caffeine may enhance analgesic response in selected settings.

✔ Multi-symptom formulation

Multiple active ingredients are combined in a single oral tablet.

9. Common Clinical Symptom Applications

Symptom	Relevant ingredient
Fever	Paracetamol
Headache	Paracetamol + caffeine
Body ache	Paracetamol
Runny nose	Chlorpheniramine
Sneezing	Chlorpheniramine
Nasal congestion	Phenylephrine
Cold-associated discomfort	Combination
Flu-like symptoms	Combination

10. Suggested Use & Dosage

The supplied artwork confirms the strength of each ingredient but does not show a dosing schedule.

Therefore, the product page should not invent a frequency or maximum daily dose.

Recommended website wording:

Take TEMPERATE-CPP Tablets only as directed by the physician.

Administration

Take orally with water.
Follow the prescribed dose and duration.
Do not exceed the recommended dose.
Do not take additional paracetamol-containing medicines without professional advice.
Avoid combining with other cold and flu preparations without checking their ingredients.

11. Drowsiness & Driving Warning

Chlorpheniramine may cause drowsiness and reduced alertness.

Patients should exercise caution when:

Driving
Operating machinery
Working at heights
Performing activities requiring mental alertness

Alcohol may increase impairment and should be avoided.

12. Side Effects

Possible adverse effects include:

Paracetamol-related

Nausea
Vomiting
Abdominal discomfort
Skin rash

Chlorpheniramine-related

Drowsiness
Dizziness
Dry mouth
Blurred vision
Constipation
Difficulty urinating

Phenylephrine-related

Increased blood pressure
Palpitations
Nervousness
Headache
Tremor

Caffeine-related

Restlessness
Nervousness
Insomnia
Tremor
Palpitations
Gastric discomfort

Not every patient will experience these effects.

13. Important Paracetamol Warning

Do not take TEMPERATE-CPP together with another medicine containing Paracetamol/Acetaminophen unless specifically advised by a healthcare professional.

Accidental duplication of paracetamol-containing cold, flu and pain medicines can result in excessive exposure and potentially serious liver injury.

Particular caution is required in patients with:

Liver disease
Significant alcohol consumption
Long-term use of other medicines affecting the liver

14. Cardiovascular Precautions

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

Inform the doctor before use if the patient has:

Hypertension
Heart disease
Arrhythmia
Hyperthyroidism
Other cardiovascular disorders

15. Other Precautions

Inform the healthcare professional if the patient has:

Liver disease
Kidney disease
High blood pressure
Heart disease
Glaucoma
Difficulty urinating
Hyperthyroidism
Alcohol dependence
Caffeine sensitivity
Sleep problems
Previous allergy to any component

16. Drug Interactions

Tell the doctor or pharmacist about all medicines being taken.

Particular attention should be given to:

Other paracetamol-containing medicines

May increase the risk of excessive paracetamol exposure.

Other antihistamines

May increase drowsiness and anticholinergic effects.

Other decongestants

May increase sympathomimetic and cardiovascular effects.

Sedatives/CNS depressants

May increase impairment caused by chlorpheniramine.

Alcohol

May increase drowsiness and impairment.

Caffeine-containing products

May increase total caffeine exposure.

17. Pregnancy & Breastfeeding

Use during pregnancy or breastfeeding should be based on medical advice and an individual risk-benefit assessment.

Patients who are:

Pregnant
Planning pregnancy
Breastfeeding

should inform their healthcare professional before taking the product.

18. Use in Children

Important regulatory warning

The formulation contains Chlorpheniramine Maleate + Phenylephrine Hydrochloride.

CDSCO has restricted this FDC combination and requires a warning that it must not be used in children below 4 years of age. The restriction applies to all formulations containing the combination.

Therefore, your website/product literature should include:

“This fixed-dose combination shall not be used in children below four years of age.”

For children aged 4 years and above, use should follow the current approved product information and medical advice.

19. Use in Elderly Patients

Elderly patients may be more susceptible to:

Drowsiness
Dizziness
Anticholinergic effects
Urinary retention
Cardiovascular effects
Drug interactions

Medical supervision is recommended.

20. Liver & Kidney Impairment

Liver

Patients with liver disease should consult a healthcare professional before use because the product contains paracetamol.

Kidney

Patients with significant renal impairment should use the product only under medical supervision.

21. When to Seek Medical Attention

Seek prompt medical attention if the patient develops:

Difficulty breathing
Facial or throat swelling
Severe allergic reaction
Severe palpitations
Chest pain
Markedly increased blood pressure
Severe or persistent vomiting
Yellowing of the eyes or skin
Accidental overdose
Severe or unusual drowsiness

Paracetamol overdose requires urgent medical assessment even if the patient initially feels well.

22. Storage

Store TEMPERATE-CPP 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.

23. Key Product Features