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Paracetamol, Caffeine, Phenylephrine & Chlorpheniramine Tablets

Composition: Two uncoated tablet variants with Paracetamol BP 325 mg, Caffeine BP 30 mg or 15 mg, Phenylephrine BP 2.5 mg and Chlorpheniramine BP 2 mg (salt forms per approved label).

Usage: Symptomatic cold-related pain, fever, sneezing and runny nose, subject to local approval.

Category: Analgesic Painkiller / Cold & Flu Formulations

Therapeutic class: Analgesic / Antipyretic / Antihistamine / Stimulant / Decongestant ingredient

SKU: Paracetamol Caffeine Phenylephrine CPM Tablets

Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations

Product Information

Paracetamol, Caffeine, Phenylephrine & Chlorpheniramine Tablets is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

Product Description

Manufacturer: Healthy Life Pharma Pvt. Ltd. Exporter: Healthy Inc. WHO-GMP status, Star Export House status and export availability should be checked against current documentation.

1. Product Introduction

These four-ingredient uncoated tablets combine paracetamol (analgesic and antipyretic), caffeine (stimulant), phenylephrine (sympathomimetic decongestant) and chlorpheniramine maleate (sedating first-generation antihistamine). The supplied range contains two distinct compositions, shown below. Any claims of relief of nasal congestion with oral phenylephrine require special caution because its efficacy at usual oral doses has been questioned by regulators.

Healthy Life Pharma Pvt. Ltd. is listed as manufacturer and Healthy Inc as exporter in the supplied product description. Contract manufacturing availability, certification and market approvals must be confirmed directly.

2. Product Specifications

VariantComposition per uncoated tabletOther details
Variant AParacetamol BP 325 mg + Caffeine BP 30 mg + Phenylephrine HCl BP 2.5 mg + Chlorpheniramine Maleate BP 2 mgSunset Yellow listed; excipients q.s.
Variant BParacetamol BP 325 mg + Caffeine BP 15 mg + Phenylephrine BP 2.5 mg + Chlorpheniramine BP 2 mgTartrazine listed; exact ingredient salt forms and colour compliance to verify

Dosage form: Uncoated tablets. Therapeutic classes: Analgesic/antipyretic, stimulant, sympathomimetic decongestant, antihistamine. SKU: Paracetamol Caffeine Phenylephrine CPM Tablets.

Note: The separately supplied 500 mg paracetamol + 30 mg caffeine + 5/10 mg phenylephrine + 2/4 mg CPM strength was not confirmed in the source compositions and is not represented as an available variant.

3. Manufacturing Technology

Four-ingredient tablet manufacture requires validated blending and content uniformity, particularly for low-dose phenylephrine and chlorpheniramine. Compatibility, stability, impurity control and excipient/colour suitability should be assessed during development. The actual process (e.g. direct compression or granulation), equipment and packaging barrier must be supported by manufacturing records; no specific process is assumed here.

4. Quality Assurance

Finished-product controls should include identity and assay of all four active ingredients, content uniformity, dissolution or disintegration as appropriate, related substances, microbial quality where applicable, and stability in the marketed pack. Acceptance limits are defined by the approved product specification and applicable pharmacopoeial/registration requirements, not a universal 100% assay target.

5. Pharmacology and Intended Use

Paracetamol: Helps relieve pain and fever. Chlorpheniramine: May reduce sneezing and runny nose but can cause sedation and anticholinergic effects. Caffeine: Stimulant that can cause insomnia or palpitations. Phenylephrine: An oral decongestant ingredient; evidence for meaningful relief of nasal congestion at usual oral doses is inadequate. The combination should not be promoted as guaranteed “total” cold/flu relief. Local approvals determine any permitted indication and age group.

6. Export and Regulatory Support

For B2B enquiries, request the approved composition, country-specific registration status, stability data, artwork, product specifications, COA and any applicable GMP, COPP or FSC documents. CTD/ACTD dossier availability, export terms and shipment routes must be confirmed for the requested market. Colour additives such as Sunset Yellow and Tartrazine may have market-specific restrictions or labelling requirements.

7. Frequently Asked Questions

Q: What is CPM?
A: CPM refers to chlorpheniramine maleate, a first-generation antihistamine.

Q: Can caffeine prevent drowsiness from CPM?
A: No. Caffeine does not reliably eliminate sedation or driving impairment caused by chlorpheniramine.

Q: Are both variants the same?
A: No. They differ in caffeine content (30 mg versus 15 mg) and list different colour additives. Labels must identify the exact variant.

Q: Is oral phenylephrine effective for blocked nose?
A: Its effectiveness at standard oral doses has been challenged by regulatory scientific reviews. Check current local regulatory status.

8. Dosage and Administration

Use only according to the approved product label and prescriber or pharmacist advice. Do not apply a generic “one tablet every 4–6 hours” instruction across countries, ages or strengths. Avoid taking additional paracetamol-containing cold remedies at the same time. Paediatric use, pregnancy, and patients with liver disease require specific assessment.

9. Side Effects and Precautions

Paracetamol: Overdose can cause severe liver injury. Chlorpheniramine: Drowsiness, dry mouth, blurred vision and urinary retention; avoid driving if impaired. Caffeine: Insomnia, anxiety and palpitations. Phenylephrine: May increase blood pressure or heart rate; caution with cardiovascular disease, hypertension and interacting medicines, including MAO inhibitors. Glaucoma and urinary retention risk require medical advice. Avoid alcohol and sedatives where relevant.

10. Storage Instructions

Store in the original, properly closed packaging, protected from moisture and excessive heat. Follow the temperature, shelf-life and light-protection conditions validated for the actual marketed formulation; no universal 25°C limit or 36-month shelf life is asserted without stability data.