Diclofenac Potassium and Paracetamol Tablets

DiclofenacPotassium Tablets 50 mg
Each Sugarcoated tablet contains:
Diclofenac Potassium BP 50 mg

Diclofenac Potassium and Paracetamol Tablets

Each uncoated Tablet contains: Diclofenac Potassium BP 50 mg
Paracetamol BP 650 mg
colour: Tartrazine –
Excipient – QS

Usage: – Muscle aches, backaches, dental pain, menstrual cramps, and sports injuries

Category: – Anti Analgesic Painkiller Drugs

Therapeutic category: – NSAID, Arthritis, Painkiller

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Description

Diclofenac Potassium and Paracetamol Tablets (50mg + 325mg)

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 Diclofenac Potassium and Paracetamol Tablets in India. This formulation is designed for Rapid Pain Relief. unlike Diclofenac Sodium, the Potassium salt dissolves faster in the stomach, leading to a quicker onset of action. Combined with Paracetamol, it offers a synergistic effect for managing acute pain, inflammation, and fever.

We offer Contract Manufacturing (Third Party) services for this high-demand analgesic. Our WHO-GMP certified facility in Mumbai utilizes high-speed tableting lines to produce cost-effective, high-quality NSAID combinations. Healthy Inc manages the export logistics, ensuring consistent supply to pharmacies, clinics, and distributors across Africa, Latin America, and Southeast Asia.

2. Product Specifications

ParameterSpecification
Product NameDiclofenac Potassium and Paracetamol Tablets
Generic NameDiclofenac Potassium & Paracetamol Tablets USP / BP / IP
CAS Number15307-81-0 (Diclofenac K) / 103-90-2 (Paracetamol)
StrengthDiclofenac Potassium 50mg + Paracetamol 325mg
Dosage FormFilm Coated Tablet
StandardUSP / BP / IP Compliant
Therapeutic ClassNSAID / Analgesic / Antipyretic
Shelf Life36 Months
Packaging10×10 Blister / 10×15 Blister / Bulk Jar

3. Manufacturing Diclofenac Potassium + Paracetamol

Optimizing for speed and stability.

  • The Manufacturer: Healthy Life Pharma Pvt. Ltd.

    The key advantage of Diclofenac Potassium is speed. We formulate these tablets to disintegrate rapidly, ensuring the drug is available for absorption within minutes. We use Wet Granulation with specific binders to ensure that the Paracetamol (which is bulky) and Diclofenac are perfectly blended, preventing segregation. We apply a thin Film Coating to mask the bitter taste of the drug without delaying its action.

  • The Exporter: Healthy Inc

    Healthy Inc ensures that the product reaches global markets securely. We use High-GSM Blister Foils to protect the tablets from physical damage and moisture during transit. We handle all logistics, offering flexible shipping options (FCL/LCL) to suit the needs of both large distributors and smaller importers.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

  • Dissolution: We test for rapid release (typically >85% in 30 minutes) to validate the “fast-acting” claim.

  • Assay: We confirm the precise ratio of 50mg Diclofenac to 325mg Paracetamol in every batch.

  • Impurities: We strictly monitor for degradation products like 4-aminophenol and related substances to ensure safety.

5. Why Use Diclofenac Potassium + Paracetamol?

It is the preferred choice for acute, sharp pain.

  • Mechanism:

    • Diclofenac Potassium: An NSAID that blocks COX-2 enzymes, reducing prostaglandins (pain and inflammation signals). Its high solubility allows it to work faster than the Sodium salt.

    • Paracetamol: Acts centrally to block pain signals and lower fever.

  • Key Indications:

    • Dental Pain: Excellent for post-extraction pain or toothache.

    • Migraine: Helps relieve acute headache pain.

    • Dysmenorrhea: Effective for severe menstrual cramps.

    • Post-Operative Pain: Management of acute pain after minor surgeries.

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 Diclofenac Potassium Paracetamol Tablets?

    A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

  • Q: What is the difference between Diclofenac Sodium and Potassium?

    A: Diclofenac Potassium is absorbed faster by the body, making it better for acute pain (like toothache). Diclofenac Sodium releases slower and is better for chronic conditions (like arthritis).

  • Q: Can this reduce fever?

    A: Yes, the Paracetamol component makes it effective for reducing fever associated with inflammation.


CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

  • Standard Dosage: One tablet every 8 hours as needed.

  • Maximum Dose: Do not exceed 3 tablets in 24 hours.

  • Administration: Take with food or milk to prevent stomach upset.

9. Side Effects and Precautions

  • Common Side Effects: Epigastric pain, nausea, heartburn, and dizziness.

  • Gastric Safety: Avoid in patients with active peptic ulcers.

  • Allergy: Do not take if allergic to Aspirin or other NSAIDs (can cause bronchospasm).

10. Storage Instructions

  • Store below 30°C in a dry place.

  • Protect from light and moisture.