US Pharm. 2010;35(10):124. 

The FDA is warning consumers not to take TimeOut Capsules because the product contains an active drug ingredient that can dangerously lower blood pressure. The product, which is marketed as a dietary supplement for sexual enhancement, is labeled as “100% natural,” and as such consumers may mistakenly assume that it is harmless and poses no health risk. The product is distributed on Internet sites and online marketplaces as 2,500-mg capsules. Consumers who have TimeOut Capsules should stop using them immediately. Sexual-enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or death, the FDA said.