Description
Paracetamol, Caffeine, Phenylephrine & Chlorpheniramine Tablets
Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)
1. Product Introduction
Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Paracetamol, Caffeine, Phenylephrine, and Chlorpheniramine Tablets in India. This is a “Total Action” Cold & Flu Formulation designed to combat the full spectrum of flu symptoms. It combines four powerful active ingredients to treat fever, pain, nasal congestion, and allergic symptoms (sneezing/runny nose) simultaneously.
We offer Contract Manufacturing (Third Party) services for this comprehensive formulation, often marketed as “Flu-Stop” or “Cold Total” tablets. Our WHO-GMP certified facility in Mumbai utilizes advanced formulation science to ensure the chemical compatibility of these four distinct ingredients. Healthy Inc manages the export logistics, supplying pharmacy chains and healthcare distributors across Africa, Southeast Asia, CIS, and Latin America.
2. Product Specifications
| Parameter | Specification |
| Product Name | Paracetamol, Caffeine, Phenylephrine & CPM Tablets |
| Generic Name | Paracetamol, Caffeine, Phenylephrine HCl & Chlorpheniramine Maleate Tablets |
| CAS Number | 103-90-2 (Para) / 58-08-2 (Caff) / 61-76-7 (PE) / 113-92-8 (CPM) |
| Strength | Paracetamol 500mg + Caffeine 30mg + Phenylephrine 5mg/10mg + CPM 2mg/4mg |
| Dosage Form | Film Coated Tablet / Caplet / Bilayer Tablet |
| Standard | USP / BP / IP Compliant |
| Therapeutic Class | Cold & Flu / Antihistamine / Decongestant / Analgesic |
| Shelf Life | 36 Months |
| Packaging | 10×10 Blister / 10×15 Blister / Bulk Jar |
3. Manufacturing Technology
Formulating a stable 4-in-1 tablet requires precision.
The Manufacturer: Healthy Life Pharma Pvt. Ltd.
Content Uniformity: Chlorpheniramine (2mg) and Phenylephrine (5mg) are potent low-dose ingredients. We use Geometric Dilution and high-shear granulation to ensure they are perfectly distributed throughout the bulk of Paracetamol (500mg). This prevents “hot spots” where a single tablet could be too potent.
Stability: Phenylephrine is sensitive to oxidation, and Paracetamol can hydrolyze. We use specific binders and antioxidants to prevent degradation.
Taste Masking: This combination is intensely bitter. We apply a robust Film Coating (Opadry) to ensure patient compliance and ease of swallowing.
The Exporter: Healthy Inc
Packaging: We prioritize PVDC-coated PVC Blisters or Alu-Alu packs. This provides a high barrier against moisture and oxygen, ensuring the stability of the Phenylephrine and CPM over the 3-year shelf life.
4. Quality Assurance
We adhere to strict Pharmacopoeial standards:
Assay: We use validated HPLC methods to simultaneously quantify all four active ingredients, ensuring 100% label claim.
Dissolution: We verify that the tablet releases all drugs rapidly to provide quick symptom relief.
Impurity Profiling: We strictly monitor for degradation products, particularly Phenylephrine impurities and 4-aminophenol.
5. Why Use This Quadruple Combination?
It provides “All-in-One” relief for severe colds.
Mechanism:
Paracetamol: Reduces fever and relieves headache/body ache.
Phenylephrine HCl: Decongestant that shrinks swollen nasal tissues to unblock the nose.
Chlorpheniramine Maleate (CPM): Antihistamine that dries up a runny nose, stops sneezing, and relieves watery eyes.
Caffeine: Counteracts the drowsiness caused by CPM and boosts the pain-relieving effect of Paracetamol.
Key Indications:
Common Cold & Flu: When symptoms include fever, pain, blocked nose, AND runny nose/sneezing.
Sinusitis with Allergy: Relieves sinus pressure complicated by allergic rhinitis.
6. Export and Regulatory Support
We streamline the registration process for our B2B partners:
Dossier Support: We offer CTD and ACTD Dossiers for quick registration.
Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.
Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).
7. Frequently Asked Questions
Q: Who manufactures this 4-in-1 Cold Tablet?
A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Does this make you sleepy?
A: It contains CPM (which causes drowsiness) and Caffeine (which promotes alertness). The caffeine helps offset the sedation, but sensitive individuals may still feel mild drowsiness. It is generally less sedating than plain CPM formulas.
Q: Why are there four ingredients?
A: To treat every symptom of the flu with one pill: Pain/Fever (Para), Fatigue (Caffeine), Blocked Nose (PE), and Runny Nose (CPM).
CLINICAL PHARMACOLOGY & SAFETY INFORMATION
(For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Standard Dosage: 1 tablet every 4 to 6 hours.
Maximum Dose: Do not exceed 4 tablets in 24 hours.
Administration: Take with water.
9. Side Effects and Precautions
CNS Effects: Drowsiness (due to CPM) or excitability/insomnia (due to Caffeine).
Cardiovascular: Phenylephrine may raise blood pressure. Use with caution in hypertensive patients.
Anticholinergic Effects: Dry mouth, blurred vision, or urinary retention (due to CPM).
Contraindications: Glaucoma, benign prostatic hyperplasia (BPH), or use of MAO inhibitors.
10. Storage Instructions
Store below 25°C in a dry place.
Protect from light and moisture.
