Stool softener and Laxatives are formulated probiotics to restore regularity to the body many are expressly produced for adults, hence getting kids friendly and matching products can be daunting at times. For the pain that comes with it, hardened stool left untreated may result in a chronic case for kids-retaining the feces in them, because they fear these painful potty woes. When passing feces become painful and difficult for babies, they are mostly to suffer from constipation. Apart from being painful, this unfortunate ailment can have an adverse effect on their eating habit and negatively alter toddlers’ sleeping patterns. nanotechnology), requires supporting data and will be reviewed outside the labelling standard.Constipation is a common bodily disorder in kids and babies. Antimicrobial preservative effectiveness should be determined in order to establish that the product is capable of resisting microbial contamination.Īny change to the manufacturing process that impacts the safety and efficacy of the ingredients, such as the use of novel technology (e.g. Where antimicrobial preservatives are added, an assay with suitable limits should be included. pH, specific gravity, and viscosity, appropriate to the dosage form. The specifications for all dosage forms should include a description of the dosage form, including organoleptic properties as well as physico-chemical testing e.g. In the absence of a Schedule B standard for any dosage form, testing must be adequate to demonstrate the product's identity, potency, purity and quality.įinished product specifications should include tests for identification and an assay with suitable limits for the medicinal ingredient(s). Where no Schedule B monograph exists for the dosage form, specifications should be similar to those of a comparable compendial dosage form. It is also noted that all products are subject to Part C, Division 2 of the Food and Drug Regulations.Īll ingredient (medicinal and non-medicinal) and finished product specifications must meet or exceed the standards described in the publications referred to in Schedule B to the Food and Drugs Act, or equivalent standards. Products must comply with the requirements in the Food and Drugs Act and associated Regulations. Both regulators will continue to explore if there may be additional opportunities for future OTC monograph initiatives. This initiative is one step in the ongoing collaboration between Health Canada and the TGA to work toward greater regulatory convergence and harmonization where feasible. The proposed Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard describes the requirements necessary to receive marketing authorization for oral antitussive non-prescription products containing dextromethorphan or dextromethorphan hydrobromide as a single ingredient for use in adults to relieve dry cough due to cold. The proposed Non-prescription Oral Stool Softener Laxatives Labelling Standard describes the requirements necessary to receive marketing authorization for non-prescription oral stool softener laxative products containing docusate sodium or docusate calcium as a single ingredient for use in adults and children 6 years of age and older for use as a stool softening laxative to relieve occasional constipation. Two labelling standards have been developed ( Non-prescription Oral Adult Antitussive Cough and Cold and Non-prescription Oral Stool Softener Laxatives) because they meet the goals of aligning the ongoing work of both regulators and reducing unnecessary differences. Health Canada and the Australian Therapeutic Goods Administration (TGA) continue to work under the Regulatory Cooperation Initiative (RCI) project to explore various ways of work sharing between the two regulatory agencies. Our file number: 15-103676-125 Regulatory Cooperation Initiative (RCI) Over-the-Counter (OTC) Products Proposed Draft Monographs for Comment
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