Module 1

Question 1

o The label should contain “This statement has not been evaluated by the FDA. The product is not intended to diagnose, treat, cure or prevent any disease”

Answer 1

Dietary supplement

Question 2

-should state specific parts of the plant used
(Supplement Facts)

Answer 2

Herbal products

Question 3

Controlled Room Temperature
• Temperature between - or sometimes -

Answer 3

20 to 25 C

15 to 30C

Question 4

Controlled Room Temperature
• Temperature between - or sometimes -

Answer 4

20 to 25 C

15 to 30C

Question 5

Warm Temperature
Any temperature between

Answer 5

30 to 40C

Question 6

Excessive Heat
Any temperature above

Answer 6

40C

Question 7

Excessive Heat
Any temperature above

Answer 7

40C

Question 8

Risks of freezing:
breakage of container;
loss of potency strength;
destructive alteration of the dosage form.

Answer 8

Protection from Freezing

Question 9

Label: Nonproprietary and Proprietary name of the drug

Answer 9

Rx drug label

Question 10

Label: Name and address of manufacturer

Answer 10

Rx drug and OTC drug

Question 11

Label: Dosage strength or potency

Answer 11

Rx drug label

Question 12

Label: Type of dosage form

Answer 12

Rx drug label

Question 13

Label: Net content

Answer 13

Rx drug and OTC Drug

Question 14

Label: Prescription logo and Legend statement

Answer 14

Rx drug label

Answer 15

X

Question 16

Label: Special storage instructions

Answer 16

Rx drug label

Question 17

Label: Bar code and Registration number

Answer 17

Rx drug label

Question 18

Label: Lot or control number

Answer 18

Rx drug label

Question 19

Label: Expiration date

Answer 19

Rx drug label, OTC label

Question 20

Label: *For controlled substances, the symbol “C” and the statement “Warning: Maybe habit-forming”

Answer 20

Rx drug label

Question 21

Label: Label reference to see the accompanying package insert

Answer 21

Rx drug label

Question 22

Label: Product name (generic and brand)

Answer 22

OTC drug label

Question 23

Label: Formulation

Answer 23

OTC drug label

Question 24

Label: Name of any habit-forming substances

Answer 24

OTC drug label

Question 25

Label: Pharmacologic category (principal intended action)

Answer 25

OTC drug label

Question 26

Label: Cautions and warnings

Answer 26

OTC drug label

Question 27

Label: Na+ content for oral preparations

Answer 27

OTC Drug label

Question 28

Label: Storage conditions

Answer 28

OTC drug label

Question 29

Label: Description of tamper-evident feature

Answer 29

OTC drug label

Question 30

Label: Lot number and expiration date

Answer 30

OTC drug label

Question 31

Cold temperature Any temperature not exceeding -

Answer 31

8C

Question 32

Refrigerator () Freezer ()

Answer 32

2 to 8C -25 to - 10C

Question 33

Cool Temperature • Any temperature between

Answer 33

8 to 15C

Question 34

• The temperature prevailing in a working area

Answer 34

Room Temperature

Question 35

• The temperature prevailing in a working area

Answer 35

Room Temperature

Question 36

•With Rx symbol, or the Legend: …. Act prohibits dispensing without prescription (#6)

Answer 36

PRESCRIPTION DRUG LABEL

Question 37

•With Rx symbol, or the Legend: …. Act prohibits dispensing without prescription (#6)

Answer 37

PRESCRIPTION DRUG LABEL

Question 38

- The statement: "Warning - May be habit forming" (#12)

Answer 38

oFor Controlled substances

Question 39

Type I - parenteral products (most resistant)

Answer 39

High-resistant borosilicate glass

Question 40

Type II

Answer 40

Treated soda-lime glass (parenteral products)

Question 41

Type III

Answer 41

Soda lime glass (parental products)

Question 42

Type NP (Other preparation)

Answer 42

General purpose soda-lime glass

Question 43

Plastic containers

Answer 43

PVC - Polyvinyl chloride PET - polyethylene terephthalate APET - amorphous polyethylene terephthalate glycol PETG - polyethylene terephthalate glycol