In the pharmaceutical industry, Paracetamol 250 mg (also known as Acetaminophen) is a standard “mid-strength” dosage primarily utilized in pediatric medicine and for specific low-dose adult requirements. As a pharmacist and manufacturer, I view this strength as the essential bridge between infant drops and adult 500 mg tablets.
At your WHO-GMP facility in Mumbai, this SKU is a high-volume product, particularly in the form of pediatric dispersible tablets or suspensions, which are core components of any primary healthcare portfolio.
Primary Clinical Indications
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Pediatric Fever (Antipyretic): The most common use for the 250 mg strength is to reduce high body temperatures in children aged 6 to 12 years.
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Mild to Moderate Pain (Analgesic): Relief of common childhood ailments such as headaches, toothaches, earaches, and post-vaccination soreness.
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Juvenile Aches: Management of “growing pains” or minor musculoskeletal discomfort in adolescents.
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Adult Low-Dose Therapy: Occasionally used for adults with low body weight or those who are extremely sensitive to higher doses of NSAIDs.
Mechanism: Central Prostaglandin Inhibition
Unlike Ibuprofen, Paracetamol works primarily within the Central Nervous System (CNS) rather than at the site of injury.
Enzyme Targeting: It is thought to inhibit the COX (Cyclooxygenase) enzymes in the brain.
Pain Threshold Elevation: By reducing prostaglandin synthesis in the CNS, it increases the body’s overall pain threshold, making the patient feel less discomfort.
Thermoregulation: It acts on the hypothalamic heat-regulating center to dissipate body heat through vasodilation and increased peripheral blood flow (sweating).
The Pharmacist’s “Technical Warning”
As you build your digital presence, providing these safety nuances is essential for clinical authority:
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The 24-Hour Limit: For children, the total dose should not exceed 60 mg/kg in a 24-hour period. Generally, this means no more than 4 doses of 250 mg in one day.
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Hepatotoxicity Risk: Paracetamol is processed by the liver. Even a slight overdose can cause severe liver damage. Ensure patients do not take it alongside other “cold and flu” remedies that might also contain Paracetamol.
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No Anti-Inflammatory Effect: Technically, Paracetamol is not an NSAID; it will reduce pain and fever but will not reduce significant swelling or inflammation.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Dispersible” USP: On your marketplace, highlight your 250 mg DT (Dispersible Tablets). These are highly valued in international health tenders (like UNICEF or WHO) because they dissolve in a teaspoon of water, making them ideal for children who cannot swallow pills.
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Stability for Export: Paracetamol is highly stable. Utilizing Blister or Strip packaging ensures a 36-to-48-month shelf life, making it a reliable “anchor product” 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 tenders and for private B2B pharmacy networks.