In the pharmaceutical industry, Paracetamol 500 mg (Acetaminophen) is the global “Gold Standard” for the management of pyrexia (fever). As a pharmacist and manufacturer, I view this molecule as the most essential antipyretic in any portfolio due to its excellent safety profile when used correctly and its high efficacy in reducing elevated body temperature.
At your WHO-GMP facility in Mumbai, Paracetamol 500 mg is likely your highest-volume SKU, serving as a foundational product for both domestic healthcare and international B2B trade.
Primary Clinical Indications
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Pyrexia (Fever): Rapidly reduces high body temperature caused by viral or bacterial infections, including the common cold, flu, and post-vaccination reactions.
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Mild to Moderate Pain: Effectively manages headaches, toothaches, and musculoskeletal pain that often accompany a fever.
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Pediatric & Geriatric Care: Because it is gentler on the gastric mucosa than NSAIDs (like Ibuprofen), it is often the preferred choice for sensitive populations.
Mechanism: Hypothalamic Thermoregulation
Paracetamol acts directly on the brain’s “thermostat” to cool the body down.
COX Inhibition: It primarily inhibits Cyclooxygenase (COX) enzymes in the Central Nervous System (CNS).
Prostaglandin Reduction: By blocking these enzymes, it reduces the production of Prostaglandin in the hypothalamus.
Heat Dissipation: This signals the body to increase peripheral blood flow and initiate sweating, effectively “venting” heat and lowering the core temperature.
The Pharmacist’s “Technical Warning”
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The “4000 mg” Ceiling: As a manufacturer, you must emphasize that the maximum daily dose for an adult is 4 grams (8 tablets of 500 mg). Exceeding this carries a severe risk of irreversible hepatotoxicity (liver damage).
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The Alcohol Alert: Advise users that chronic alcohol consumption significantly increases the risk of liver injury, even at standard doses of Paracetamol.
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Hidden Ingredients: Warn patients to check other “Cold & Flu” multi-symptom relief products to ensure they aren’t accidentally doubling up on Paracetamol.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Fast-Release” USP: On your marketplace, highlight if your 500 mg tablets utilize advanced disintegration technology. Faster-dissolving tablets reach therapeutic levels in the blood more quickly, a major selling point for B2B buyers.
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Stability for Export: Paracetamol is highly stable. Utilizing PVC/PVDC or Alu-Alu blister packaging ensures a robust 36-month shelf life, vital for export to Zone IVb tropical regions.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders (WHO/UNICEF) and for private B2B pharmacy networks.