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Hyland's began selling products in Canada in 1990. [2] In 2013, the FDA conducted a review of Hyland's labeling and marketing information which revealed numerous products misbranded in violation of sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 353 and 331]. This review included the products for ...
The FDA is also cautioning consumers about off-label use of quinine to treat leg cramps. [19] [20] Quinine is approved for treatment of malaria, but was also commonly prescribed to treat leg cramps and similar conditions. Because malaria is life-threatening, the risks associated with quinine use are considered acceptable when used to treat that ...
The pharmacy CVS announced, also on September 30, that it was voluntarily withdrawing the products from sale [129] and on October 11 Hyland's (the manufacturer) announced that it was discontinuing their teething medicine in the United States though the products remain on sale in Canada. [130]
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Besides being painful, a nocturnal leg cramp can cause much distress and anxiety. [14] The precise cause of these cramps is unclear. Potential contributing factors include dehydration , low levels of certain minerals ( magnesium , potassium , calcium , and sodium , although the evidence has been mixed), [ 15 ] [ 16 ] [ 17 ] and reduced blood ...
Rhino pills and other non-prescription supplements aren’t regulated by the U.S. Food and Drug Administration (FDA) like medications are, and there’s rarely much science to back their claims.