COLLEGE OF NURSING AND PHARMACY

C-PPD1 – DISPENSING 1 (DISPENSING PROCESS, READING &

INTERPRETING THE PRESCRIPTION AND OTHER MEDICINE ORDERS)
First Semester | AY 2021-2022

Module 3: Labelling
Time Frame: Week 7 & 8 (8hours)
Schedule of synchronous sessions:

Mapped Learning Outcomes and Course Content for C-PPD1 Dispensing 1, Module 3
Target Learning Outcomes Content and Activities
Hour (At the close of the period allotted, Online Session Offline Session
students should have :)
8 hours  Determining the Interactive lecture: Worksheets Activity for Laboratory
information on the drug Labelling Written Report#3: Pharmaceutical
label required by FDA. Labelling
 Preparing a label of unit -Definition of Terms
dose, reconstituted, -Pharmaceutical
external and sterile Labelling
compounding preparation. -General Guidelines
for Labelling
Requirements

1. Content / Discussion / Learning Resources / Link

Labelling of Dispensed Drug

Definition of Terms
◉ Dispensing refers to the sum of processes performed by a pharmacist from reading, validating, and
interpreting prescriptions; preparing; packaging; labeling; record keeping; dose calculations; and
counseling or giving information, in relation to the sale or transfer of pharmaceutical products, with
or without a prescription or medication order
◉ Label refers to a display of written, printed, or graphic matter on the immediate container of any
article;
◉ Labeling materials refer to all labels and other written, printed, or graphic matter: (1) upon any
item or any of its containers or wrappers; or (2) accompanying any such an article.

Sec. 36 of RA 10918
Label of Dispensed Medicines
◉ the name of patient
◉ generic name of drug;
◉ brand name, if any,
◉ strength,
◉ expiry date,
◉ directions for use;
◉ name and address of pharmacy,
◉ name of the doctor,
◉ name of the dispensing pharmacist 
◉ Other requirements*

Faculty: Jethro M. Ocampo, RPh Page 1 of 8

 COLLEGE OF NURSING AND PHARMACY
C-PPD1 – DISPENSING 1 (DISPENSING PROCESS, READING &
INTERPRETING THE PRESCRIPTION AND OTHER MEDICINE ORDERS)
First Semester | AY 2021-2022

◉ Auxiliary labels containing special pharmacists' instructions for the patient shall be required as
prescribed for dangerous drugs,
◉ External-use-only drugs, drugs with special storage and administration instructions and such other
drugs as may be required by law

◉ The purpose of a label for a prescribed medicine is:

○ To describe and identify it
○ To contribute to optimal therapeutic outcome and to avoid medication errors
○ To achieve appropriate handling and storage
○ To allow the product to be traced if there are problems with either the manufacturing,
prescribing or dispensing process
*FIP GUIDELINES FOR THE LABELS OF PRESCRIBED MEDICINES

A.O. 2016-0008 Revised Rules and Regulations Governing the Generic Labelling Requirements of
Drug Products for Human Use

GENERAL GUIDELINES
◉ The following are the minimum mandatory information that shall appear in the labeling materials
accompanying a drug product:
(a) Product Name
(b) Dosage Form and Strength
(c) Pharmacologic Category
(d) Formulation/Composition
(e) Indication(s)
(f) Dosage and Mode of Administration
(g) Contraindication(s), Precaution(s), Warning(s) (if applicable)
(h) Interactions
(i) Adverse Drug Reaction(s)

Faculty: Jethro M. Ocampo, RPh Page 2 of 8

 COLLEGE OF NURSING AND PHARMACY
C-PPD1 – DISPENSING 1 (DISPENSING PROCESS, READING &
INTERPRETING THE PRESCRIPTION AND OTHER MEDICINE ORDERS)
First Semester | AY 2021-2022

(j) Overdose and Treatment

(k) Storage Condition(s)
(l) Net Content or Pack Size
(m) Name and Address of MAH
(n) Name and Address of Manufacturer
(o) For prescription drug products, Rx Symbol and Caution Statement
(p) ADR Reporting Statement
(q) Registration Number
(r) Batch Number and Lot Number (if any)
(s) Expiration Date and Date of Manufacture

PHARMACEUTICAL LABELLING

LABEL
“ Label means a display of written, printed or graphic matter upon immediate container or the wrapper of a
drug package”

TYPES OF LABEL
•
Manufacturer label
•
Dispensing label

Manufacturer label
• A label which contain drug information for the use of medical practitioners, pharmacists, or nurses
supplied by the manufacturer, packer, or distributor of the drug (FDA)

LEGAL REQUIRMENTS OF A MANUFACTURER LABEL

1. The name of preparation
2. Strength and dosage form.
3. Quantity.
4. Instructions for the use.
5. Precautions & warnings.
6. Registration number.
7. Batch number.
8. Manufacturing & Expiry date .
9. Price
10. The name and address of pharmaceutical industry

NAME OF THE PREPARATION

Generic name:
“ International non-proprietary name means the name of a drug as recommended by WHO or may be
notified by the federal govt. in the official gazette”

Brand Name:
•
Brand name which is used to market the drug
•
Property of drug company
STRENGTH
• It is amount of active drug per unit dose.
• Example: amoxicillin 250mg capsules and amoxicillin 500mg capsules.

Faculty: Jethro M. Ocampo, RPh Page 3 of 8

 COLLEGE OF NURSING AND PHARMACY
C-PPD1 – DISPENSING 1 (DISPENSING PROCESS, READING &
INTERPRETING THE PRESCRIPTION AND OTHER MEDICINE ORDERS)
First Semester | AY 2021-2022

SPECIFICATION
•
U.S.P
•
B.P

DOSAGE FORM
• Dosage form of the medicine should be mentioned on the label. e.g.,
• Different dosage forms of Amoxicillin

QUANTITY
Quantity /volume present per a packaging unit

INSTRUCTIONS

Shake well before use:

Necessary on all disperse systems: Emulsions, Suspensions
e.g., Liniments Lotions Tinctures

Warning!!!!!
DO NOT SHAKE THE PATIENT,
SHAKE THE BOTTLE WELL BEFORE USE…….

Precautions

Storage conditions
Store in a cool place:
1. Not more than 0˚C-8˚C is necessary for many products

Faculty: Jethro M. Ocampo, RPh Page 4 of 8

 COLLEGE OF NURSING AND PHARMACY
C-PPD1 – DISPENSING 1 (DISPENSING PROCESS, READING &
INTERPRETING THE PRESCRIPTION AND OTHER MEDICINE ORDERS)
First Semester | AY 2021-2022

Protect from light:

•
Necessary for light sensitive preparations.
•
Light resistive containers should be used.

Keep out of the reach of children

•
All dispensed medicines should carry this information on label

For external use only:

Inflammable:
If the preparation contain 50% or more alcohol or any other inflammable solvent, the label should contain
word inflammable

Not to be taken:
◉ Liquid preparation that are not administered by mouth
◉ For nasal drops, enemas and nasal sprays
◉ Unit dosage forms e.g., pessaries and rectal suppositories
◉ Help to administer drugs safely

Types of warnings
If hypersensitivity to a drug
•
For controlled substances
•
About combining with other drugs or products

Registration number
•
“A number given to a specific drug when it is registered according to specific rules by registration board set
up by federal government”

Batch number
•
“A designation printed on label of a drug that identifies the batch and permits the production history of the
batch including all stages of manufacturer and control to be traced and are viewed”

Manufacturing date

Expiry date
•
“Date stated on the label of a drug after which a drug is not expected to retain its claimed efficacy, safety,
quantity, or potency or after which it is no permissible to sell the drug”

Faculty: Jethro M. Ocampo, RPh Page 5 of 8

 COLLEGE OF NURSING AND PHARMACY
C-PPD1 – DISPENSING 1 (DISPENSING PROCESS, READING &
INTERPRETING THE PRESCRIPTION AND OTHER MEDICINE ORDERS)
First Semester | AY 2021-2022

License number
•
Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act.
The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the
product

Manufacturer information
•
Name
•
Address

Price

Barcodes
•
“It is an optical machine readable representation of data, which shows data about the object to which it
attaches”

DISPENSING LABEL
It includes:
•
Drug name and quantity
•
Patient name
•
Prescription number
•
Phone number
•
Instruction for use
•
Pharmacy name and address

SPECIAL INSTRUCTIONS
Includes the information about:
1. Directions for use:
◉ How to take a medicine

Faculty: Jethro M. Ocampo, RPh Page 6 of 8

 COLLEGE OF NURSING AND PHARMACY
C-PPD1 – DISPENSING 1 (DISPENSING PROCESS, READING &
INTERPRETING THE PRESCRIPTION AND OTHER MEDICINE ORDERS)
First Semester | AY 2021-2022

EAR DROPS
•
For external use only

AEROSOLS INHALATIONS
•
Pressurized containers keep away from heat source
•
Shake before use
•
Do not exceed the prescribed dose

CREAMS
•
For external use only
•
Store in cool place

Interactions
• Certain drugs may have serious reactions if eat with particular food or drugs,e.g:
a) Amine containing foods (tyrosine) with monoamine oxidase inhibitors.(hypertension crises)
b) Tetracycline with milk

LABORATORY WORKSHEET

WRITTEN REPORT NO. 2

PHARMACEUTICAL LABELLING

Group Work: (30pts)

◉ As a pharmacist, design a suitable label in accordance to RA 10918

Name of Product (5pts)

Label needs to be appealing to shoppers in a store's aisles

Label Layout (5pt)

Product clearly named and identified with visual of front label and back label/list of ingredients (as needed).

Content Accuracy (15pts)

Information are put in accordance with the RA 10918 Labelling Requirements

Color Usage (5pts)

Uses a variety of colors

Faculty: Jethro M. Ocampo, RPh Page 7 of 8

 COLLEGE OF NURSING AND PHARMACY
C-PPD1 – DISPENSING 1 (DISPENSING PROCESS, READING &
INTERPRETING THE PRESCRIPTION AND OTHER MEDICINE ORDERS)
First Semester | AY 2021-2022

2. Evaluation of Learning

For the evaluation of learning for Module 3, a scheduled quiz will be assigned in the Google Classroom and
will be taken before the start of the next Module during the Synchronous Class.

References

Adams, C.H. and Jones, P.D. Therapeutic communication for health professionals (2011/latest edition)

Blenkinsopp, A. and Panton, R. Health promotion for pharmacists (1991/latest edition)

Gupta, GD, NK Jain, Modern Dispensing Pharmacy (2011)

Pharmacists talking with patients: a guide to patient counseling / Melanie J. Rantucci. (2012)

Congratulations for having completed this C-PPD1 Module 3! See you in the next Module

Faculty: Jethro M. Ocampo, RPh Page 8 of 8