TEMPERATE COLD Tablets

Paracetamol 500 mg + Phenylephrine Hydrochloride 5 mg + Chlorpheniramine Maleate 2 mg + Caffeine (Anhydrous) 30 mg

TEMPERATE COLD is a four-component cold and flu symptomatic formulation containing an analgesic/antipyretic, nasal decongestant, antihistamine and caffeine. The artwork specifies an uncoated tablet containing Paracetamol 500 mg, Phenylephrine HCl 5 mg, Chlorpheniramine Maleate 2 mg and Caffeine (Anhydrous) 30 mg.

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1. Product Information

Composition

Each uncoated tablet contains:

• Paracetamol IP — 500 mg
• Phenylephrine Hydrochloride IP — 5 mg
• Chlorpheniramine Maleate IP — 2 mg
• Caffeine (Anhydrous) IP — 30 mg
• Excipients — q.s.

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2. What is TEMPERATE COLD Used For?

TEMPERATE COLD is intended for symptomatic management of selected common-cold and upper-respiratory symptoms, under professional medical direction.

The ingredients address different symptoms:

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

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

• Common-cold-associated headache
• Fever
• Body ache
• Runny nose
• Sneezing
• Nasal congestion
• Sinus-related discomfort
• Upper-respiratory cold symptoms

Clinical research has evaluated combinations containing paracetamol, chlorphenamine and phenylephrine for symptomatic common-cold treatment in adults.

Important: The exact indication for TEMPERATE COLD should follow its current approved product permission, prescribing information and applicable Indian regulatory requirements.

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3. Mechanism of Action

A. Paracetamol 500 mg

Paracetamol is an analgesic and antipyretic.

Analgesic action

It acts predominantly through central mechanisms involved in pain processing and helps reduce the perception of pain.

Antipyretic action

It acts centrally to reduce elevated body temperature associated with fever.

Therefore, paracetamol addresses symptoms such as:

• Headache
• Body ache
• Fever
• General discomfort associated with cold and flu

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4. Phenylephrine Hydrochloride 5 mg

Phenylephrine is an adrenergic decongestant.

It produces vasoconstrictive effects through alpha-adrenergic receptor activity, which can reduce swelling of the nasal mucosa and thereby contribute to relief of nasal congestion.

Intended symptomatic role

Nasal congestion → reduced nasal mucosal swelling → easier nasal breathing

Important qualification

The effectiveness of oral phenylephrine as a nasal decongestant has been questioned, and this issue has been specifically discussed in CDSCO’s historical FDC evaluations. Therefore, website content should avoid claiming guaranteed or rapid decongestant efficacy.

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5. Chlorpheniramine Maleate 2 mg

Chlorpheniramine is a first-generation H1 antihistamine.

It reduces histamine-mediated symptoms and can help control:

• Runny nose
• Sneezing
• Nasal symptoms
• Watery eyes associated with allergic-type symptoms

Because chlorpheniramine can cross the blood-brain barrier, it may cause drowsiness and reduced alertness in some individuals.

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6. Caffeine (Anhydrous) 30 mg

Caffeine is included as an analgesic adjuvant.

It may enhance the analgesic effect of certain analgesics in selected acute-pain situations and may counter some of the subjective sedating effects associated with first-generation antihistamines in some patients.

Its presence should not be interpreted as making the product suitable for prolonged or excessive use.

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7. Combined Action

TEMPERATE COLD combines four pharmacological components:

Overall concept

Pain + Fever
↓
Paracetamol

Nasal congestion
↓
Phenylephrine

Runny nose + Sneezing
↓
Chlorpheniramine

Analgesic adjuvant
↓
Caffeine

This provides a multi-symptom approach for selected cold/flu presentations.

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8. Potential Therapeutic Benefits

✔ Pain and fever relief

Paracetamol provides the principal analgesic and antipyretic activity.

✔ Multi-symptom approach

The formulation addresses several common cold-associated symptoms through different active ingredients.

✔ Nasal symptom support

Phenylephrine provides the decongestant component.

✔ Runny nose and sneezing

Chlorpheniramine provides antihistamine activity.

✔ Analgesic adjuvant

Caffeine may contribute to analgesic enhancement.

✔ Convenient oral dosage form

Four active ingredients are combined into one tablet.

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9. Common Clinical Applications

Under appropriate medical supervision, the formulation may be considered for symptomatic treatment involving:

A clinical study of a paracetamol/phenylephrine/chlorphenamine combination reported improvement in overall common-cold symptom scores compared with placebo in adults.

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10. Suggested Use & Dosage

The artwork confirms the strength and composition, but it does not state a complete dosing schedule. Therefore, a specific dose frequency should not be invented for the product page.

Administration

• Take orally with water.
• Use only according to the physician’s instructions.
• Do not exceed the prescribed dose.
• Avoid taking another medicine containing paracetamol at the same time unless specifically advised.
• Avoid combining with other cold/flu medicines without checking their ingredients.

Important

Because the product contains multiple pharmacologically active ingredients, it should not be used simply because several cold symptoms are present without considering whether each component is actually required.

This issue has been specifically discussed in CDSCO’s FDC evaluations, including concern about unnecessary exposure to ingredients when patients may require only one or some of them.

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11. Drowsiness & Driving Warning

Chlorpheniramine may cause drowsiness or reduced alertness.

Patients should exercise caution with:

• Driving
• Operating machinery
• Working at heights
• Other activities requiring full mental alertness

Alcohol may increase CNS impairment and should be avoided.

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12. Side Effects

Possible adverse effects may include:

Paracetamol-related

• Nausea
• Vomiting
• Abdominal discomfort
• Skin rash

Chlorpheniramine-related

• Drowsiness
• Dry mouth
• Dizziness
• Blurred vision
• Constipation
• Difficulty urinating in susceptible individuals

Phenylephrine-related

• Increased blood pressure
• Palpitations
• Nervousness
• Headache
• Tremor

Caffeine-related

• Restlessness
• Nervousness
• Insomnia
• Tremor
• Palpitations
• Gastric discomfort

Not every patient experiences these effects.

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13. Important Paracetamol Warning

Do not take TEMPERATE COLD together with another paracetamol/acetaminophen-containing medicine without professional advice.

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

Patients with liver disease or significant alcohol consumption require particular caution.

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14. Cardiovascular Precautions

Because TEMPERATE COLD contains phenylephrine, caution is particularly important in patients with cardiovascular conditions.

Patients should inform their doctor if they have:

• Hypertension
• Heart disease
• Arrhythmia
• Coronary artery disease
• Hyperthyroidism
• Other cardiovascular disorders

This is particularly relevant to this FDC because the CDSCO January 2024 pathway for specified formulations requires the package insert to include a caution for patients suffering from cardiovascular diseases.

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15. Other Precautions

Inform your doctor before use if you have:

• Liver disease
• Kidney disease
• High blood pressure
• Heart disease
• Glaucoma
• Enlarged prostate or difficulty urinating
• Hyperthyroidism
• Alcohol dependence
• Sensitivity to caffeine
• Sleep disorders
• Previous allergy to any component

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16. Drug Interactions

Tell your healthcare professional about all medicines you are taking.

Particular caution may be required with:

Other paracetamol-containing products

May cause excessive total paracetamol exposure.

Other antihistamines

May increase antihistamine-related adverse effects and sedation.

Other decongestants

May increase cardiovascular or sympathomimetic effects.

Sedatives and CNS depressants

May increase drowsiness associated with chlorpheniramine.

Alcohol

May increase impairment and may increase concerns associated with sedating antihistamines.

Caffeine-containing products

Excessive additional caffeine may increase nervousness, insomnia or palpitations.

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17. Pregnancy & Breastfeeding

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

Patients should inform their healthcare professional if they are:

• Pregnant
• Planning pregnancy
• Breastfeeding

Because this is a multi-ingredient formulation, unnecessary exposure to individual components should be avoided.

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18. Use in Children

Important regulatory warning

Current CDSCO information includes an August 2026 notification prohibiting all formulations containing the fixed-dose combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride in children below four years of age. TEMPERATE COLD contains both of these ingredients.

Therefore:

TEMPERATE COLD should not be promoted or recommended for children below 4 years of age.

For older children, use should follow the current approved product information and a healthcare professional’s direction.

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19. Use in Elderly Patients

Elderly patients may be more susceptible to:

• Drowsiness
• Dizziness
• Anticholinergic effects
• Urinary retention
• Blood-pressure effects
• Drug interactions

Medical supervision is therefore particularly important.

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20. Liver & Kidney Impairment

Liver impairment

Paracetamol requires particular caution in patients with liver disease or excessive alcohol consumption.

Kidney impairment

Patients with significant renal impairment should consult a healthcare professional before use.

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21. When to Seek Medical Attention

Seek medical attention if symptoms are severe, worsening or persistent, particularly if there is:

• Difficulty breathing
• Chest pain
• Severe palpitations
• Very high or persistent fever
• Severe headache
• Facial swelling
• Severe allergic reaction
• Confusion or extreme drowsiness
• Accidental overdose
• Yellowing of the skin or eyes
• Severe or persistent vomiting

If an excessive amount of paracetamol has been taken, urgent medical assessment is required even if the patient initially feels well.

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22. Storage

Store TEMPERATE COLD:

• 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 the tablets after the expiry date.

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23. Key Product Features

TEMPERATE COLD Tablets

Four-component symptomatic cold formulation

• Paracetamol IP — 500 mg
• Phenylephrine Hydrochloride IP — 5 mg
• Chlorpheniramine Maleate IP — 2 mg
• Caffeine (Anhydrous) IP — 30 mg
• Uncoated tablet
• Oral administration
• Designed for physician-directed symptomatic management of selected cold/flu symptoms
• 30 × 10 tablets pack shown on artwork

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24. Product Positioning

Multi-symptom cold support

TEMPERATE COLD combines ingredients addressing different symptom categories:

Analgesic + Antipyretic
Paracetamol

Decongestant
Phenylephrine

Antihistamine
Chlorpheniramine

Analgesic Adjuvant
Caffeine

This makes the product conceptually suited to multi-symptom cold presentations, rather than isolated fever or isolated nasal symptoms.

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25. Regulatory Note for Amcare Website

I recommend adding a small internal regulatory check before publishing this particular product page as a promotional pharmaceutical page.

CDSCO’s current FDC resources list approved, prohibited and restricted FDC information, and the agency’s January 2024 notice specifically lists Caffeine 15/30 mg + Paracetamol 500 mg + Phenylephrine 5 mg + Chlorpheniramine 2 mg among compositions for which continued manufacturing/marketing was recommended subject to specified conditions.

The same CDSCO records also show that this class of FDC has undergone substantial regulatory scrutiny, including historical concerns regarding rationality and dosing.

For your final Amcare product catalogue, I would therefore keep the wording “symptomatic relief” rather than making stronger claims such as “cures cold,” “treats infection,” or “fastest decongestion.”