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Australian regulatory guideline for overthecounter medicines Appendix 5: Guidelines on OTC application for specific substancesVersion 1.0, October 2012Therapeutic Goods AdministrationAbout the Therapeutic
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How to fill out over-form-counter medicines
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Read the label and follow the instructions provided by the manufacturer.
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Take the medicine at the recommended intervals and do not exceed the maximum daily dose.
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Who needs over-form-counter medicines?
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It is important to note that certain medical conditions, age groups, and pregnancy may require consultation with a healthcare professional before using over-the-counter medicines.
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Always read the label and follow the instructions to ensure safe and appropriate use.
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What is over-form-counter medicines?
Over-the-counter (OTC) medicines are drugs that are available to consumers without a prescription.
Who is required to file over-form-counter medicines?
Manufacturers, distributors, and retailers of over-the-counter medicines are required to file them.
How to fill out over-form-counter medicines?
Over-the-counter medicines are typically reported using the FDA's MedWatch form or through the electronic submission system.
What is the purpose of over-form-counter medicines?
The purpose of reporting over-the-counter medicines is to monitor the safety and efficacy of these products.
What information must be reported on over-form-counter medicines?
Information such as adverse events, product quality issues, and labeling errors must be reported on over-the-counter medicines.
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