Description
Paracetamol, Caffeine and Phenylephrine 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, and Phenylephrine Tablets in India. This is a premium “Non-Drowsy” Cold & Flu Formulation designed for daytime relief. It targets the three most debilitating symptoms of the common cold: fever/pain, fatigue, and nasal congestion.
We offer Contract Manufacturing (Third Party) services for this high-demand OTC product. Unlike traditional cold medicines containing antihistamines (which cause sleepiness), this formula uses Caffeine to keep the patient alert and Phenylephrine to clear blocked noses without sedation. Our WHO-GMP certified facility in Mumbai utilizes advanced blending technology to ensure the stability of Phenylephrine while masking the bitter taste of the active ingredients. Healthy Inc manages the export logistics, supplying pharmacy chains and distributors across Africa, Southeast Asia, and the Middle East.
2. Product Specifications
| Parameter | Specification |
| Product Name | Paracetamol, Caffeine & Phenylephrine Tablets |
| Generic Name | Paracetamol, Caffeine & Phenylephrine Hydrochloride Tablets USP / BP / IP |
| CAS Number | 103-90-2 (Paracetamol) / 58-08-2 (Caffeine) / 61-76-7 (Phenylephrine) |
| Strength | Paracetamol 500mg + Caffeine 30mg + Phenylephrine HCl 5mg / 10mg |
| Dosage Form | Film Coated Tablet / Caplet |
| Standard | USP / BP / IP Compliant |
| Therapeutic Class | Cold & Flu / Decongestant / Analgesic |
| Shelf Life | 36 Months |
| Packaging | 10×10 Blister / 10×15 Blister / Bulk Jar |
3. Manufacturing Technology
Creating a stable triple-combination requires precise formulation.
The Manufacturer: Healthy Life Pharma Pvt. Ltd.
Stability: Phenylephrine HCl is sensitive to oxidation and moisture. We use specific antioxidants and binders in the granulation process to prevent degradation.
Uniformity: Phenylephrine is present in a small dose (5-10mg). We use High-Shear Mixing and geometric dilution to ensure it is perfectly distributed throughout the tablet, preventing dose variation.
Taste Masking: All three ingredients are bitter. We apply a specialized Film Coating (Opadry) to ensure the tablet is easy to swallow and tasteless.
The Exporter: Healthy Inc
Protection: We use PVDC-coated PVC Blisters or Alu-Alu packs to provide a high barrier against moisture, ensuring the Phenylephrine remains potent throughout the 3-year shelf life.
4. Quality Assurance
We adhere to strict Pharmacopoeial standards:
Assay: We simultaneously test for all three ingredients using HPLC to ensure 100% label claim.
Dissolution: We verify that the tablet releases drugs rapidly to provide quick relief from headache and congestion.
Impurity Profiling: We strictly monitor for Phenylephrine degradation products and 4-aminophenol.
5. Why Use This Triple Combination?
It is the ideal “Daytime” solution for cold and flu.
Mechanism:
Paracetamol: Reduces fever and relieves body aches and headaches.
Phenylephrine HCl: A potent vasoconstrictor that shrinks swollen blood vessels in the nasal passages, clearing a blocked nose.
Caffeine: Counteracts the fatigue/drowsiness associated with the cold and enhances the pain-relieving effect of Paracetamol.
Key Indications:
Common Cold: Relief of congestion, headache, and fever.
Sinusitis: Relieves sinus pressure and pain.
Flu: Manages body aches and fatigue.
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 Paracetamol Caffeine Phenylephrine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Will this make me sleepy?
A: No. This is a non-drowsy formula because it contains Caffeine and does not contain sedating antihistamines (like Chlorpheniramine).
Q: Is it safe for high blood pressure patients?
A: No. Phenylephrine can raise blood pressure. Hypertensive patients should consult a doctor before use.
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
Cardiovascular: Phenylephrine may cause palpitations or increased blood pressure. Caffeine may cause tachycardia.
CNS: Insomnia, nervousness, or dizziness.
Contraindications: Do not use in patients taking MAO Inhibitors (antidepressants) or those with severe hypertension or hyperthyroidism.
10. Storage Instructions
Store below 25°C in a dry place.
Protect from light and moisture.
