Description
Paracetamol and Orphenadrine Citrate 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 and Orphenadrine Citrate Tablets in India. This Skeletal Muscle Relaxant Combination is designed to provide dual-action relief for painful muscle spasms. It combines Orphenadrine Citrate (a potent muscle relaxant with anticholinergic properties) and Paracetamol (a centrally acting analgesic).
We offer Contract Manufacturing (Third Party) services for this formulation, often prescribed for acute musculoskeletal conditions. Our WHO-GMP certified facility in Mumbai utilizes advanced blending techniques to ensure the stability of the Citrate salt alongside Paracetamol. Healthy Inc manages the export logistics, supplying orthopedic clinics, pharmacies, and distributors across Africa, the Middle East, and Latin America.
2. Product Specifications
| Parameter | Specification |
| Product Name | Paracetamol and Orphenadrine Citrate Tablets |
| Generic Name | Paracetamol & Orphenadrine Citrate Tablets USP / BP |
| CAS Number | 103-90-2 (Paracetamol) / 4682-36-4 (Orphenadrine Citrate) |
| Strength | A: Paracetamol 450mg + Orphenadrine Citrate 35mg
B: Paracetamol 650mg + Orphenadrine Citrate 50mg |
| Dosage Form | Film Coated Tablet / Bilayer Tablet (Optional) |
| Standard | USP / BP Compliant |
| Therapeutic Class | Muscle Relaxant / Analgesic |
| Shelf Life | 36 Months |
| Packaging | 10×10 Blister / 10×15 Blister / Bulk Jar |
3. Manufacturing Technology
Formulating muscle relaxants requires precise control over content uniformity.
The Manufacturer: Healthy Life Pharma Pvt. Ltd.
Orphenadrine Citrate is a low-dose ingredient compared to the bulky Paracetamol. We use Geometric Dilution during the granulation phase to ensure the muscle relaxant is evenly dispersed throughout the tablet matrix. We utilize Film Coating technology to mask the bitter taste of Orphenadrine and improve swallowing ease for patients in pain.
The Exporter: Healthy Inc
Healthy Inc ensures global reach. We use High-GSM Blisters (PVC/PVDC) to protect the Citrate salt from moisture degradation. We are experienced in handling the regulatory documentation required for muscle relaxants, which are prescription-only medicines (POM) in many territories.
4. Quality Assurance
We adhere to strict Pharmacopoeial standards:
Dissolution: We test the release rates of both drugs to ensure rapid onset of action (muscle relaxation usually begins within 30-60 minutes).
Assay: We confirm the potency of both active ingredients to ensure 100% label claim.
Related Substances: We monitor for impurities to ensure the product remains safe and effective over its 3-year shelf life.
5. Why Use Paracetamol + Orphenadrine?
It targets the pain-spasm-pain cycle.
Mechanism:
Orphenadrine: Acts centrally in the brain stem to block nerve impulses that cause muscles to spasm.
Paracetamol: Increases the pain threshold effectively treating the pain caused by the spasm.
Key Indications:
Muscle Spasms: Acute back pain, neck pain (“wry neck”), and strains.
Tension Headaches: Relief of headaches caused by tight neck muscles.
Trauma: Pain relief following soft tissue injuries (whiplash).
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 Orphenadrine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Does this make you sleepy?
A: Yes, Orphenadrine has a mild sedative effect which helps patients rest and recover from muscle injuries.
Q: Is this the generic for Norgesic?
A: Yes, this formulation is similar to the popular brand Norgesic.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION
(For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Standard Dosage: One tablet twice or three times daily.
Administration: Can be taken with or without food.
Duration: Generally recommended for short-term use during the acute phase of injury.
9. Side Effects and Precautions
Common Side Effects: Dry mouth, blurred vision, dizziness, and drowsiness (anticholinergic effects).
Contraindications: Do not use in patients with Glaucoma, Myasthenia Gravis, or Prostatic Enlargement (BPH).
Driving: Patients should avoid driving or operating heavy machinery if they feel drowsy.
10. Storage Instructions
Store below 30°C in a dry place.
Protect from light.







