Search on: BLACK BOX WARNING 
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Descriptor English:   Drug Labeling 
Descriptor Spanish:   Etiquetado de Medicamentos 
Descriptor Portuguese:   Rotulagem de Medicamentos 
Synonyms English:   Black Box Warning
Boxed Warning
Drug Labelling
Black Box Warnings
Box Warning, Black
Box Warnings, Black
Boxed Warnings
Drug Package Insert
Drug Package Inserts
Drug Product Labeling
Insert, Drug Package
Inserts, Drug Package
Labeling, Drug Product
Labelling, Drug
Package Insert, Drug
Warning, Black Box
Warning, Boxed
Warnings, Black Box
Warnings, Boxed
Package Inserts, Drug
Product Labeling, Drug
Visual Identity of Drugs
Labeling, Drug
Drug Labelling  
Tree Number:   E05.916.310
J01.576.655.750.321.400
J01.576.761.300.400
VS2.002.002.001.001.003
Definition English:   Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information. 
See Related English:   Off-Label Use
 
History Note English:   68 
Allowable Qualifiers English:  
CL classification EC economics
ES ethics HI history
IS instrumentation LJ legislation & jurisprudence
MA manpower MT methods
ST standards SN statistics & numerical data
TD trends  
Record Number:   4410 
Unique Identifier:   D004348 

Occurrence in VHL:
 

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