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

INTERNSHIP 1
Exercise 8
Labeling Prescription
and Medications


Key Terms
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
Outer label means the label on or
affixed to the outside package of an
article. Example carton label
KeyTerms
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
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
Auxiliary labels are placed on drug product
containers to give the patient, healthcare
provider important information needed for
using the product
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
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
Packaging the activity of designing and producing
the container or wrapper for a product
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




1. Differences between Inpatient and
outpatient label


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



1. identification of the dispensing
pharmacy
2. patients name
3. date of dispensing
4. name of the drug
5. strength




Auxiliary labels


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. Cold 2
0
C to 8
0
C
2. Cool 8
0
C to 15
0
C
3. Room temperature 20
0
C to 25
0
C
4. Warm 30
0
C to 40
0
C
5. Excessive heat above 40
0
C
6. Protection from freezing

By: Nelson T. Tubon; B.S. Pharm.; B.S.S.Ed; R.Ph.;M.S. Pharm.;Ph.D. B.M.
INTERENSHIP 1
Exercise 9

Drug Labels and
Packaging
Key Terms
Component means any ingredient intended
for use in the manufacturing of drugs
including those that not appear in the finished
product
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
Active Ingredient means any substance
of a drug which is intended to furnish
pharmacologic activity
Strength means concentration of known
active drug substance in formulation
Brand name refers to the proprietary,
trade name assigned to the product by the
drug establishment
Pharmacologic category refers to the
classification of the product based on its
therapeutic action as specified in the product
registration
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
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
Contraindications refers to statements
regarding the conditions wherein the use of
the product may cause harm to the patient

Key Terms
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
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
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
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
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
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
KEY TERMS

Inactive ingredient means any substance
other than active ingredient present in a drug
Formulation refers to the name/s and
amount/s of active medicinal ingredients per
dosage unit expressed in the metric system
Dosage forms means the pharmaceutical
form of the preparation based on official
pharmacopeia

Mode of administration refers to the site
and manner the product is to be introduced
into or applied on the body
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



KEY TERMS


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
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


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


1. D
2. J
3. G
4. I
5. A
6. C
7. H
8. B
9. E
10. F

A.Drug Packaging