LAS 2 Flashcards
a display of written, printed, or graphic matter upon the immediate container
Label
means ALL labels and other written, printed, or graphic matter upon any article or any of its containers.
Labelling
label that is affixed to an immediate container
Inner label
label that is affixed to the outside of the package
Outer label
preparation in the final form for market presentation of the product
Packaging material
this is produced according to single manufacturing order during the SAME CYCLE OF MANUFACTURE.
Batch number
a drug produced in a unit of time or quantity in a manner that assures its uniformity and quality within specified limits.
Lot number
refers to the amount of intake of the drug at a given frequency interval, condition and time of administration.
Dosage
refers to the site and manner the drug is introduced into the body.
Mode of administration
information about the occurrence of serious potential hazards and side effects associated to the drug
Warning
the condition wherein drug may cause harm to the patient
Contraindication
This are instructions and special care to avoid undesired effects from the drug
Precautions
it contains information applying only to the product and its active ingredient
Package insert
It is the period beyond which pharmaceutical specialty is not expected to have retained its pharmacologic attributes to guarantee its safety, quality, and purity.
Expiration date
It is the total amount/quantity of the dosage form in a certain container of a pharmaceutical product
Net content
It is the prevailing specified temperature, humidity, and other environmental factors within which a range will ensure optimal stability
Storage conditions
The word “POISON” and vignette representing a skull and cross should be in…?
big letters and on red labels
“External use only” should be in…?
red labels; in & out packaging inserts
This refers to the active ingredient and the amount expressed per dosage unit.
Formulation
what is the group drug assignment?
Ambroxol (extended release)
what are the titles on las 2?
Guidelines on preparing packaging inserts
Guidelines on labeling drug products
