In the pharmaceutical industry, Paracetamol 650 mg (often referred to by the brand name Dolo 650 or P-650 in India) is a staple analgesic and antipyretic. Because this is a higher-strength formulation compared to the standard 500 mg, the margin for safety is narrower.
Maximum Daily Dosage
For a healthy adult weighing at least 50 kg, the absolute maximum limit is:
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4,000 mg (4 grams) in a 24-hour period.
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In terms of 650 mg tablets, this equates to no more than 6 tablets in 24 hours.
The “Pharmacist’s Rule” for Administration
To maintain a steady therapeutic level while ensuring safety at your manufacturing or trading firm, we follow these guidelines:
Dosing Interval: 1 tablet every 4 to 6 hours.
Minimum Gap: Never take doses closer than 4 hours apart.
Duration: Do not use for more than 3 consecutive days for fever or 10 days for pain without a doctor’s consultation.
The Technical Danger: Hepatotoxicity
As a pharmacist, you know that Paracetamol is metabolized primarily in the liver.
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The Pathway: Normally, Paracetamol is converted into non-toxic metabolites. However, a small portion is converted into a highly reactive intermediate called NAPQI.
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The Overload: The liver uses Glutathione to neutralize NAPQI. When you exceed the 4,000 mg limit, Glutathione stores are depleted.
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The Result: Un-neutralized NAPQI begins to bind directly to liver cells, causing acute hepatic necrosis (liver failure).
Manufacturer’s Quality & Compliance Notes
From a production and B2B export perspective at a WHO-GMP facility:
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Alcohol Warning: It is vital that your Product Information Leaflet (PIL) clearly warns against consuming alcohol while taking 650 mg tablets, as alcohol depletes glutathione and significantly increases the risk of liver damage.
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Hidden Paracetamol: In the export market, many “Cold & Flu” powders or “Cough Syrups” also contain Paracetamol. As a trading firm owner, you must educate buyers to check the “Total Daily Intake” across all combined medications.
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Dossier Support: At your Mumbai facility, ensuring that the Dissolution Profile of your 650 mg tablet is optimized is key. A faster dissolution (within 15-30 minutes) is a major USP for digital marketing, as it implies faster pain relief.