Description

Paracetamol, Diclofenac Sodium & Caffeine Tablets

(500mg / 50mg / 30mg)

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, Diclofenac Sodium, and Caffeine Tablets in India. This is a potent “Triple Action” Analgesic specifically formulated for severe headaches, migraines, and intense musculoskeletal pain.

This Fixed-Dose Combination (FDC) attacks pain from three angles: Diclofenac reduces inflammation; Paracetamol blocks pain signals centrally; and Caffeine constricts cerebral blood vessels (helping migraines) while boosting the absorption and efficacy of the other two analgesics by up to 40%. It is widely prescribed as a “Strong Painkiller” when monotherapy fails.

We offer Contract Manufacturing (Third Party) services for this high-volume formulation. Combining three bitter drugs requires expertise. Our WHO-GMP certified facility in Mumbai utilizes advanced Taste-Masking Granulation and Film Coating technologies to produce a tablet that is effective, stable, and patient-friendly. Healthy Inc manages the export logistics, supplying pharmacy chains and distributors across Africa, the CIS region, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

The migraine specialist.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Stabilization: Diclofenac Sodium is reactive. We use specific excipients (buffers) in the granulation process to prevent it from reacting with Paracetamol, ensuring the tablet remains chemically stable and white (preventing discoloration) throughout its shelf life.

  • Rapid Release: Migraines require speed. We utilize Super-Disintegrants (like Sodium Starch Glycolate) to ensure the tablet breaks down in the stomach within minutes, flooding the system with pain-relieving agents before the headache fully sets in.

  • Taste Masking: All three ingredients are bitter. Our High-Gloss Opadry Coating ensures the tablet slips down the throat easily without leaving a metallic aftertaste.

• The Exporter: Healthy Inc

  • Power Branding: We specialize in designing “High Impact” packaging (using metallic foils and bold colors like red/silver) that communicates strength and speed on the retail shelf.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of all three drugs release within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: Strict monitoring of 4-Aminophenol (Paracetamol impurity) and Diclofenac-related compounds (Indolinone) to ensure safety.

5. Why Use This Combination?

The ultimate headache hammer.

• Mechanism:

  1. Diclofenac (The Anti-Inflammatory): Potent NSAID that inhibits COX-2 enzymes, stopping the production of prostaglandins that cause inflammation and pain.

      

  2. Paracetamol (The Central Blocker): Increases the pain threshold in the brain.

  3. Caffeine (The Booster):

     • Vasoconstriction: Migraine pain is often caused by dilated blood vessels in the brain pushing on nerves. Caffeine shrinks these vessels, providing relief.

     • Absorption: It creates a more acidic environment in the stomach which helps the drugs dissolve and absorb faster.

• Key Indications:

  • Migraine: Aborts acute attacks.

  • Tension Headache: Relieves the “tight band” feeling.

  • Musculoskeletal Pain: Back pain, dental pain, and post-injury soreness.

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 these tablets?

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

• Q: Is it stronger than plain Paracetamol?

  A: Yes, significantly. The addition of Diclofenac and Caffeine makes it much more potent. It should only be used for severe pain.

• Q: Can I take it on an empty stomach?

  A: NO. Diclofenac can irritate the stomach lining. Always take this tablet after a meal to prevent acidity or stomach pain.

• Q: Is it addictive?

  A: Caffeine can be mildly habit-forming. Do not take daily for long periods (to avoid “Rebound Headaches”).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 1 tablet every 8 hours as needed.

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

• Administration: Swallow whole with water immediately after food.

9. Side Effects and Precautions

• Gastrointestinal: Acidity, heartburn, nausea, gastric ulcer risk (due to Diclofenac).

• Cardiovascular: Elevated blood pressure (due to Caffeine/Diclofenac).

• Renal: Avoid in patients with kidney impairment.

• Contraindications: Active Peptic Ulcer, Asthma (NSAID-sensitive), Severe Heart Failure, Pregnancy (Third Trimester).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.