Labeling drug facts

OTC drug facts" labeling Summary of essential information needed for safe and effective use of the drug Consumers... 

The regulation requires a standardized Drug Facts label on more than... 

Mania is a special danger in regard to Xanax. Unlike any other benzodiazepine, the FDA-approved label for Xanax, as found in the 2007 Physicians Desk Reference, specifically mentioned the risk of mania. Drug Facts and Comparisons (2007) also made a specific reference to Xanax under Precautions, stating that anger, hostility and episodes of mania and hypomania have been reported with alprazolam (p. 1199). As another... 

The New Drug Facts Label http //www.bemedwise.org/ label/label.htm (accessed Oct 17, 2002). 

This putative new concept can account for the reason why rokitamycin acts as a bactericidal agent against susceptible cells despite the fact that " C-labeled rokitamycin Ki = 3.4 X 10" M), a 3"-0-propionyl derivative of leucomycin Aj, has about half as much affinity for the ribosome as erythromycin = 1.6 x 10" M) does. In fact, " C-labeled rokitamycin is hardly replaced by nonlabeled rokitamycin, when the labeled drug had previously been bound to ribosomes from susceptible S. aureus [34, 51]. 

Figure 13-1 Drug facts—chlorpheniramine maleate 2 mg. (The new Drug Facts labeling requirements do not apply to dietary supplements, which are regulated as food products, and are labeled with a Supplement Facts panel.)...

As a researcher and therapist, I also do not like the use of colloquial terms such as addict or junkie. These terms, although potentially helpful for some who find recovery in self-help programs, are not useful for everyone with a drug problem, and can be demeaning to some. In fact, some of my clients have been put off by such labels in treatment, and found them stigmatizing, and therefore potentially harmful. Besides, such terms are highly pejorative and uncomplimentary descriptions of behavior and are not diagnostically accurate terms (i.e., are not defined in the DSM-IV). I choose not to use these terms with my own clients for these reasons. 

If an excipient had been observed, it would need to be identified. In Fig. 13.34, the drug substance standard is applied on lane 1 next to the extracted tablet. The remaining lanes labeled 2-12 are individual excipients in this particular tablet. Only one excipient, number 6, appears and it does in fact have the same R value as the band observed in the tablet. This confirmatory test is commonly used to identify interfering excipients. Now this band can be labeled appropriately, rather than mistakenly labeled as a degradant or impurity. 

Approximately 10% of new chemical entities (NCEs) show serious adverse drug reactions (ADRs) after market launch. Such events usually result in new black box warnings by the US Food and Drug Administration (FDA), label change or market withdrawal. The most common causes for these actions are hepatic toxicity, hematologic toxicity and cardiovascular toxicity [2], Reasons for such ADRs, which are identified only after NCEs are launched on the market, include the narrow spectrum of clinical disorders and participating patient profiles in clinical studies as well as the fact that serious ADRs are often rare and that the number of patient exposures required to identify such occurrences sometimes may range over a few millions [3],... 

In accordance with the provisions of the Dietary supplement Health and Education Act 1994, in the United States botanical dosage forms can be marketed as dietary supplements provided the label makes no medical claim however, structure-function claim is allowed. In most countries other than the United States, botanical preparations are regulated as drugs thus posing a different set of challenges. This fact must be taken into consideration in standard setting. 

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