Paracetamol 500mg Tablets

Paracetamol 500mg Tablets: What the Published Guidance Says

The three non-opioid analgesics named on the WHO Model List — paracetamol, ibuprofen and acetylsalicylic acid — in the full range of oral, rectal and injectable presentations, plus the wider NSAID family.

Paracetamol 500mg Tablets is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the Analgesics & NSAIDs range overview.

• Paracetamol is an antipyretic and analgesic — not an anti-inflammatory The Model List carries a footnote stating paracetamol is not recommended for anti-inflammatory use due to lack of proven benefit to that effect. Marketing copy that positions paracetamol as an anti-inflammatory is inconsistent with the WHO listing. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
• Fever control is part of severe-disease management MSF guidance on severe malaria directs paracetamol in the event of high fever only — a reminder that in febrile illness the antipyretic is supportive care, not the disease treatment. MSF Medical Guidelines — Malaria (Chapter 4.3, Parasitic infections)
• Age limits worth building into your labelling Ibuprofen is not indicated in children less than three months of age according to the Model List. Paediatric paracetamol dosing should follow national formulary weight bands. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)

Each point above is reproduced because it has a practical consequence for Paracetamol 500mg Tablets: the strength you can register, the pack you can release, or the wording permitted on the label. Your national prescribing information always takes precedence.

How Paracetamol 500mg Tablets Is Tested and Released

Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.

Release testing for Paracetamol 500mg Tablets follows the monograph you nominate — USP, EP, BP or CP. If the presentation is not covered by a monograph, the specification is frozen in writing with your quality team before the batch is manufactured.

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

Release testing on this presentation is built around:

• Testing for description and identification
• Testing for assay of the active substance
• Testing for related substances and impurities
• Testing for dissolution or release profile (solid oral forms)
• Testing for uniformity of dosage units
• Testing for water content and pH where applicable

COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.

How Paracetamol 500mg Tablets Is Packed, Labelled and Shipped

• Pack size: Blister pack (PVC-Alu) or HDPE bottle, typically 100 tablets per bottle or 10 tablets per blister strip. Non-standard pack sizes can be quoted against your artwork.
• Storage: Store below 25°C, in a dry place, protected from light and moisture. Keep container tightly closed. Do not freeze..
• Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
• Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
• Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.

Regulatory Support for Paracetamol 500mg Tablets

The legal manufacturer named on every document for Paracetamol 500mg Tablets is Sinophare Bio-technology Co., Ltd., DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. The same entity appears on the GMP certificate and on the dossier submitted to your regulator.

• Method validation, stability protocol and the shelf-life justification for the marketed pack.
• Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
• Tender and framework documentation, including pre-qualification questionnaires and sample logistics.
• Artwork and mock-up approval pack, showing the carton, label and leaflet exactly as they will be printed for your market.
• Batch manufacturing and packaging records released for inspection on request during supplier audits.

Paracetamol 500mg Tablets is presented here against non-opioid analgesics and NSAIDs named in the WHO Model List. Inclusion in an essential-medicines list does not authorise sale in any particular country — the marketing authorisation for that market is a separate step.