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American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category".
[96] [97] [98] In 2014, however, the FDA has developed a "Pregnancy and Lactation Labeling Rule (PLLR)" which requires product labels to include specific information related to the safety and effectiveness of medications to pregnant and lactating women. This ruling has removed the requirement of stating pregnancy categories in prescription drug ...
3 Pregnancy category in drugbox template. 2 comments. 4 Pregnancy category for theophylline. 1 comment. 5 Neutral Point of View? 2 comments. 6 "Categorization of ...
The FDA pregnancy classification is removed from this infobox, and does not show any more. By FDA, it is replaced by the Pregnancy and Lactation Labeling Rule (PLLR) of December 2014. The PLLR is descriptive, and not suitable for this infobox. [1]
Toggle Pregnancy category subsection. 1.1 Australia (AU) 1.2 Pregnancy category in general. 1.3 United States (US) 2 See also. Toggle the table of contents.
In the US, alcohol is subject to the FDA drug labeling Pregnancy Category X (Contraindicated in pregnancy). Alcohol is known to cause fetal alcohol spectrum disorder. [citation needed] There are a wide range of affects that Prenatal Alcohol Exposure (PAE) can have on a developing fetus.
Always follow instructions on the label and store supplements properly. Vitamin B supplement risks It's generally safe to consume vitamin B supplements in the right dosage, the experts note.
The details of label includes the name of preparation, quantity of drugs, instructions for patients, patient's name and the date of dispensing Drug labelling , also referred to as prescription labelling , is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug.