Description

Paracetamol, Caffeine & Phenylephrine Hydrochloride Tablets

(500mg / 30mg / 10mg)

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 specialized “Non-Drowsy” Cold & Flu Formulation designed for active adults. Unlike standard cold medicines that contain antihistamines (which cause sleepiness), this “Daytime” formula relieves symptoms while keeping the patient alert.

It targets the “Sinus Headache” triad: Paracetamol treats the pain and fever; Phenylephrine clears the blocked nasal passages; and Caffeine enhances the pain-relieving effect of Paracetamol while counteracting fatigue.

We offer Contract Manufacturing (Third Party) services for this high-demand OTC product. The formulation involves three distinct APIs with different physical properties. Our WHO-GMP certified facility in Mumbai utilizes advanced Wet Granulation and blending techniques to ensuring content uniformity, particularly for the low-dose Phenylephrine. Healthy Inc manages the export logistics, supplying pharmacy chains and supermarkets across Africa, the Middle East, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Powering through the cold.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: Paracetamol and Caffeine are both intensely bitter. We use a high-quality Opadry Film Coating with sweeteners/flavors (like Vanilla or Menthol) to make the tablet palatable and easy to swallow.

  • Content Uniformity: Phenylephrine (10mg) is a small dose compared to Paracetamol (500mg). We use Geometric Dilution during the blending process to ensure the decongestant is evenly distributed throughout the batch, so every tablet works effectively.

  • Binder Selection: We use specific binders (like PVP K-30) that create a robust tablet hard enough to survive shipping but engineered to disintegrate rapidly (< 15 mins) in the stomach for quick relief.

• The Exporter: Healthy Inc

  • OTC Branding: We specialize in attractive, consumer-facing blister designs (Alu-PVC or Alu-Alu) suitable for over-the-counter retail display.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test the release profile of all three active ingredients simultaneously to ensure immediate bioavailability.

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

• Impurity Profiling: Strict monitoring of 4-Aminophenol (a Paracetamol degradation product) to ensure safety.

5. Why Use This Combination?

Relief without the “fog.”

• Mechanism:

  1. Paracetamol: Reduces fever and blocks pain signals in the brain (COX inhibitor).

  2. Phenylephrine: A powerful vasoconstrictor. It shrinks the swollen blood vessels in the nasal lining, opening up the airways so you can breathe.

  3. Caffeine:

     • Adjuvant: It increases the analgesic potency of Paracetamol by ~40%.

     • Vasoconstriction: It helps constrict dilated blood vessels in the brain, relieving headaches.

     • Alertness: It combats the fatigue and “heavy head” feeling associated with colds.

• Key Indications:

  • Sinus Headache: Pressure and pain around the eyes/forehead.

  • Cold & Flu: Fever, body ache, and blocked nose.

  • Non-Drowsy Relief: For people who need to drive or work.

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: Does it make you sleepy?

  A: NO. It contains Caffeine and no antihistamines. It is designed to keep you awake and alert.

• Q: Can I take it with coffee?

  A: Be careful. One tablet has about as much caffeine as half a cup of coffee. Taking it with too much coffee might make you jittery or cause heart palpitations.

• Q: Is it safe for High Blood Pressure?

  A: Consult a doctor. Phenylephrine and Caffeine can raise blood pressure. Hypertensive patients should use it with caution.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 1 tablet every 4 to 6 hours as needed.

• Maximum Dose: Do not exceed 4 tablets in 24 hours.

• Administration: Swallow whole with water. Do not crush.

9. Side Effects and Precautions

• Cardiovascular: Palpitations, increased heart rate, elevated blood pressure.

• CNS: Insomnia (sleeplessness), restlessness, nervousness.

• Gastrointestinal: Nausea, gastric irritation.

• Liver Warning: Contains Paracetamol. Overdose causes severe liver damage. Do not take with other Paracetamol-containing drugs.

• Contraindications: Severe Hypertension, Hyperthyroidism, Coronary Artery Disease.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.