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Dosage Forms Lec > Module 1 > Flashcards

Module 1 Flashcards

1
Q

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”

A

Dietary supplement

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2
Q

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

A

Herbal products

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3
Q

Controlled Room Temperature
• Temperature between - or sometimes -

A

20 to 25 C

15 to 30C

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4
Q

Controlled Room Temperature
• Temperature between - or sometimes -

A

20 to 25 C

15 to 30C

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5
Q

Warm Temperature
Any temperature between

A

30 to 40C

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6
Q

Excessive Heat
Any temperature above

A

40C

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7
Q

Excessive Heat
Any temperature above

A

40C

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8
Q

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

A

Protection from Freezing

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9
Q

Label: Nonproprietary and Proprietary name of the drug

A

Rx drug label

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10
Q

Label: Name and address of manufacturer

A

Rx drug and OTC drug

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11
Q

Label: Dosage strength or potency

A

Rx drug label

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12
Q

Label: Type of dosage form

A

Rx drug label

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13
Q

Label: Net content

A

Rx drug and OTC Drug

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14
Q

Label: Prescription logo and Legend statement

A

Rx drug label

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15
Q
A

X

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16
Q

Label: Special storage instructions

A

Rx drug label

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17
Q

Label: Bar code and Registration number

A

Rx drug label

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18
Q

Label: Lot or control number

A

Rx drug label

19
Q

Label: Expiration date

A

Rx drug label, OTC label

20
Q

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

A

Rx drug label

21
Q

Label: Label reference to see the accompanying package insert

A

Rx drug label

22
Q

Label: Product name (generic and brand)

A

OTC drug label

23
Q

Label: Formulation

A

OTC drug label

24
Q

Label: Name of any habit-forming substances

A

OTC drug label

25
Q

Label: Pharmacologic category (principal intended action)

A

OTC drug label

26
Q

Label: Cautions and warnings

A

OTC drug label

27
Q

Label: Na+ content for oral preparations

A

OTC Drug label

28
Q

Label: Storage conditions

A

OTC drug label

29
Q

Label: Description of tamper-evident feature

A

OTC drug label

30
Q

Label: Lot number and expiration date

A

OTC drug label

31
Q

Cold temperature
Any temperature not exceeding -

A

8C

32
Q

Refrigerator ()
Freezer ()

A

2 to 8C

-25 to - 10C

33
Q

Cool Temperature
• Any temperature between

A

8 to 15C

34
Q

• The temperature prevailing in a working
area

A

Room Temperature

35
Q

• The temperature prevailing in a working
area

A

Room Temperature

36
Q

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

A

PRESCRIPTION DRUG LABEL

37
Q

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

A

PRESCRIPTION DRUG LABEL

38
Q
  • The statement: “Warning - May be habit forming” (#12)
A

oFor Controlled substances

39
Q

Type I
- parenteral products (most resistant)

A

High-resistant borosilicate glass

40
Q

Type II

A

Treated soda-lime glass (parenteral products)

41
Q

Type III

A

Soda lime glass (parental products)

42
Q

Type NP
(Other preparation)

A

General purpose soda-lime glass

43
Q

Plastic containers

A

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

Dosage Forms Lec (2 decks)

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