INTERNSHIP 1

By: Nelson T. Tubon; B.S. Pharm.; B.S.S.Ed; R.Ph.;M.S. Pharm.;Ph.D. B.M.

Exercise 8

Labeling Prescription
and Medications

Key Terms
n Labeling - means all labels and other

written, printed or graphic matter (1)

upon any article or any of its
containers or wrappers (2)
accompanying such articles
n Outer label means the label on or
affixed to the outside package of an
article. Example carton label

KeyTerms
n Principal display panel means the part of

the label that is most likely to be displayed,

presented, shown, or examined under
customary conditions of display for retail sale
n Cosmetics means articles intended to be
rubbed, poured, sprinkled, or sprayed on,
introduced into or otherwise applied to the
human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or
altering appearance

Key Terms
n Auxiliary labels are placed on drug product

containers to give the patient, healthcare

provider important information needed for
using the product
n Label means a display of written, printed or
graphic matter upon any article or any of its
container or wrappers or attached to or
accompanying such article
n Inner label means the label on or affixed to
an immediate container

Key Terms
Packaging materials means all items used or
attached to blind, enclose or contain the preparation in
the final form for market presentation of the product
n Packaging the activity of designing and producing
the container or wrapper for a product
n Devices instrument, apparatus, or contrivance,
including their components, parts, and accessories,
intended for use in diagnosis, treatment, cure,
prevention, mitigation of disease in man and animal
n

1. Differences between Inpatient and

outpatient label
n Outpatient
a. name and address of pharmacy
b. name of patient
c. name of prescriber
d. direction for use
e. date dispensed
f. cautionary statements, if any
g. serial number of prescription
h. name or initial of dispensing pharmacist
i. quantity dispensed
j. expiration
k. number of refills, etc.

Inpatient
Label of single unit packages should include
1. name of the drug
2. route of administration, unless oral
3. strength, if applicable, volume of the product,

expressed when possible in the metric system

4. control number and expiration date
5. if repackaged, identification of the repackager
6. special storage conditions, if needed

Multiple dose
n 1.
n 2.
n 3.
n 4.
n 5.

identification of the dispensing

pharmacy
patients name
date of dispensing
name of the drug
strength

Auxiliary labels
n
n
n
n
n
n
n
n
n
n
n
n
n
n
n

Shake well
Keep in the refrigerator, Do not Freeze
Do not use after
Refrigerate, Shake well, Discard After
External Use Only
May cause drowsiness; Alcohol and Operating Car or Machine Warning
Do not Drink Alcohol
Avoid Sun Exposure
Take with food
Take on an Empty Stomach
Finish all this medication
Do not take Aspirin
Keep Out of the Reach of Children
This prescription May be Refilled _____________ Times
Cancer Chemotherapy, Dispose of Properly

Terms generally employed in

storage labeling
1.
n 2.
n 3.
n 4.
n 5.
n 6.

Cold 20 C to 80 C
Cool 80 C to 150 C
Room temperature 200 C to 250 C
Warm 300 C to 400 C
Excessive heat above 400 C
Protection from freezing

INTERENSHIP 1

By: Nelson T. Tubon; B.S. Pharm.; B.S.S.Ed; R.Ph.;M.S. Pharm.;Ph.D. B.M.

Exercise 9

Drug Labels and

Packaging

Key Terms
n Component means any ingredient intended

for use in the manufacturing of drugs

including those that not appear in the finished
product
n Lot means batch or any portion of a batch
of a drug produced by a continuous process,
an amount of drug produced in a unit of time
or quantity in a manner that assures its
uniformity and in either case which is
identified by a distinctive lot number and has
uniform character and quality within specified
limits

KEY TERMS
n Active Ingredient means any substance

of a drug which is intended to furnish

pharmacologic activity
n Strength means concentration of known
active drug substance in formulation
n Brand name refers to the proprietary,
trade name assigned to the product by the
drug establishment

Key Terms
n Pharmacologic category refers to the

classification of the product based on its

therapeutic action as specified in the product
registration
n Indication refers to the approved clinical
use of the product based on substantial and
scientifically supported evidence of the safety
and efficacy of the drug in the given dosage
form

Key Terms
n Warning - refers to the instruction and

special care required in the use of product to

avoid undesired effects and to ensure the
safe and effective use of the drug
n Contraindications refers to statements
regarding the conditions wherein the use of
the product may cause harm to the patient

KEY TERMS
n Expirations refers to the date after which

the product is not expected to retain its

claimed safety, efficacy and quality or
potency or after which it is not permissible
to sell, distribute or use said product
n Net Content refers to the total amount/
quantity/number of the dosage form in a
certain container of a product expressed in
metric system

KEY TERMS
n Batch means a specific homogeneous

quantity of a drug or in a case of drug

produced according to single manufacturing
order during the same cycle of manufacture
n Lot number means any distinctive
combination of letters or numbers, or both,
by which the complete history of the
manufacture, control, packaging and
distribution of a batch or lot of a drug is
determined

KEY TERMS
n Materials approved unit means an

organizational element having the authority

and responsibility to approve or reject raw
materials, in process materials, packaging
components, and final product
n Generic name refers to the identification of
drugs and medicines by their scientifically and
internationally recognized active ingredient as
determined by the BFAD of DOH

KEY TERMS
n Inactive ingredient means any substance

other than active ingredient present in a drug

n Formulation refers to the name/s and
amount/s of active medicinal ingredients per
dosage unit expressed in the metric system
n Dosage forms means the pharmaceutical
form of the preparation based on official
pharmacopeia

KEY TERMS
n Mode of administration refers to the site

and manner the product is to be introduced

into or applied on the body
n Precautions refers to the instructions and
special care required in the use of product to
avoid undesired effects and to ensure the
safe and effective use of the drug

KEY TERMS
n Storage conditions refers to the

prevailing specified range of temperature,

humidity, and other environmental factors
within optimal stability of the product is
ensured based on laboratory data
n Date of manufacture for products other
than biological products means the date
(month and year) during which the
processing of the product, from which the
goods are to be filled, is completed

n POWDERS for external use are usually

described as dusting powders, usually

contain starch, talc, and zinc stearate
n DRESSINGS external applications
resembling ointment usually used as a
covering or protection.
n CREAMS viscous liquid or semi-solid
emulsions of either the oil in water or
water in oil type

A.Drug Packaging

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

D
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G
I
A
C
H
B
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