Labelling

Question 1

Provision of ADEQUATE INFORMATION and ACCURATE IDENTIFICATION of the pre-packaged for and drugs

Answer 1

Labeling

Question 2

Labeling is a

Answer 2

VERY IMPORTANT FEATURE of a finished product

Question 3

A display of WRITTEN, PRINTED or GRAPHIC MATTER upon the immediate container

Answer 3

Label

Question 4

Everything found on the package should serve a

Answer 4

Purpose

Question 5

Items used or attached to BIND, CLOSE or CONTAIN the drug preparation in the final form.

Answer 5

Packaging material

Question 6

13 digit barcode is for

Answer 6

Primary
Secondary

Question 7

14 digit barcode is for

Answer 7

Tertiary

Question 8

Arrangement in the barcode

Answer 8

Country code
Company code
Product code
Check digit

Question 9

Each barcode has a

Answer 9

Single keeping unit (SKU)

Question 10

Is medical devices INCLUDED as a drug or drug product?

Answer 10

No

Question 11

What does drug or drug product include

Answer 11

Herbal or traditional products listed in PNDF

Question 12

Drug or drug product is also known as

Answer 12

Finished product

Question 13

Ready to be SOLD and MARKETED

Answer 13

Finished product

Question 14

Parts of a label

Answer 14

Principal display panel
Information panel

Question 15

Portion of the label most likely to be SEEN by the consumer

Answer 15

Principal display panel

Question 16

PDPs percentage of the surface area

Answer 16

40%

Question 17

PDP is also known as the

Answer 17

Customary view

Question 18

Right or left of PDP

Answer 18

Information panel

Question 19

A PRIMARY LABEL where all information except PDP is contained

Answer 19

Information panel

Question 20

PDP includes

Answer 20

Rx symbol
Generic name
Dosage strength
Dosage form
Pharmacologic category
MAH
Net content

Question 21

Information panel contains

Answer 21

Formulation
Indication
Contraindications, warnings, precautions
Mode of administration/directions for use
Batch/lot number
Manufacture/expiration date
Registration number
(Rx)
Storage conditions

Question 22

HEIGHT of the Rx symbol

Answer 22

Not less than 1/5 of the PDP height

Question 23

Rx symbol should be printed using

Answer 23

Contrasting color

Question 24

Has the HIGHEST POINT size

Answer 24

Generic name

Question 25

Genetic name should be printed in

Answer 25

Full

Question 26

Genetic name is BASED on

Answer 26

INN in coordination with WHO Intentional Nomenclature Name

Question 27

Naming 2/more APIs according to

Answer 27

DECREASING dosage strength

Question 28

The genetic name should be ENCLOSED by a

Answer 28

OUTLINE BOX to give EMPHASIS

Question 29

It is the COLLECTIVE TERM

Answer 29

Generic class name

Question 30

Units for CONCENTRATION

Answer 30

Metric system

Question 31

Units for POTENCY

Answer 31

International unit

Question 32

Dosage strength includes

Answer 32

Concentration Potency

Question 33

It is always BESIDE the dosage strength

Answer 33

Dosage form

Question 34

Company started in the MARKETING AUTHORIZATION responsible for quality and compliance

Answer 34

Complete name and address of manufacturer, distributor, trader and repacker (MAH)

Question 35

TOTAL AMOUNT of the DF in a given container

Answer 35

Net content

Question 36

The net content should be Unit Location

Answer 36

Metric system Right upper side of box/generic name

Question 37

Formulation must include

Answer 37

Content in DECREASING PHARMACOLOGIC ACTIVITY Excipients causing HYPERSENSITIVITY Alcohol content

Question 38

Formulations included must be responsible for the

Answer 38

Therapeutic use

Question 39

Percentage of alcohol used in drugs

Answer 39

NMT 15%

Question 40

INTENDED USE

Answer 40

Indication

Question 41

Emphasis on the PATIENTS CONDITION

Answer 41

Contraindications

Question 42

It is more HAZARDOUS

Answer 42

Warnings

Question 43

Specific amount for a particular AGE BRACKET

Answer 43

Mode of administration/Dosage and administration

Question 44

Instructions on HOW TO USE

Answer 44

Directions for use

Question 45

Batch or lot number is

Answer 45

Alpha numeric

Question 46

Expiry date month is up to the

Answer 46

Last day

Question 47

What is the expiry date if a reconstituted product is kept in REFRIGERATOR

Answer 47

14 days

Question 48

What is the expiry date if a reconstituted product is NOT kept in REFRIGERATOR

Answer 48

7 days

Question 49

Number provide upon REGISTRATION FROM FDA

Answer 49

Registration number

Question 50

An information for pharmacists

Answer 50

Rx label

Question 51

Set of instructions for OPTIMAL CONDITIONS to preserve stability

Answer 51

Storage condition

Question 52

The MOLECULE or ION

Answer 52

Active moiety

Question 53

Substance or compound INTENDED to be used in the manufacture

Answer 53

API

Question 54

Response to a medicine that is NOXIOUS and UNINTENDED

Answer 54

ADR

Question 55

Any product of BIOLOGICAL ORIGIN

Answer 55

Biological product

Question 56

Name assigned to the product by the MAH

Answer 56

Brand name

Question 57

Ingredient added INTENTIONALLY

Answer 57

Excipient

Question 58

A PHARMACEUTICAL FORM of an active ingredient or placebo

Answer 58

Investigational product

Question 59

PI is for

Answer 59

Prescription products

Question 60

PIL

Answer 60

Non-prescription and in layman's term

Question 61

A drug substance that is INACTIVE

Answer 61

Prodrug