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Product Monograph Template

How do you write a product monograph?
A product monograph is an authentic document which contains scientific inputs on a medicine.
It contains characteristics, claims, conditions and limitations for which it is offered, directions, warnings and other information that is required for sale and effective use of product.
What does product monograph mean?
A product monograph is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug.
What are the guidelines for product monograph?
The product monograph should also include: contraindications, dosage and administration, symptoms and treatment of overdosage, dosage forms, warnings, precautions, adverse reactions, drug interactions, effects on laboratory tests, storage and stability, special handling instructions, pharmaceutical information,
However, a major difference was acknowledged: unlike package inserts or medication guides that are reviewed and approved by the FDA, a pharmacy monograph patient information sheet is not reviewed or regulated by the FDA.

How do you write a product monograph?