Requirements for Labeling

Materials of Pharmaceutical
Products
 Outline

 Box outline
 Definition of Terms
 General Requirements
 Specific Requirements
 Summary
Definition of Terms
 Labeling Materials

 Includes the label on the immediate container

 Printed materials that are made available with the product at
the time of purchase and/ or where the product is used.
 Outer wrapper cartons
 Leaflet/ package insert

 Provide accurate and necessary detailed info. For ID and

proper used of the product
Types of packaging materials
 Product

 Refers to pharmaceutical products

 Any pharmaceutical or biological product intended
for used in the diagnosis, cure, mitigation, treatment
or prevention of disease in human, or to affect the
structure or any function of the human body.
 Brand name

 The proprietary/ trade name assigned to the product

by the drug establishment.
 Generic Name

 The identification of drugs and medicines by their

scientifically and internationally recognized active
ingredients determined by the FDA.
 Pharmacologic category

 The classification of the product based on its

therapeutic action as specified in the product
registration.
 Formulation

 The name/s and amount/s of active medicinal

ingredients per dosage unit expressed in the metric
system.
 Indication

 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.
 Dosage form

 The pharmaceutical form of the preparation based

on official pharmacopoeia.
 Mode of Administration

 The site and manner the product is to be introduced

in to or applied on the body.
 Warnings

 Are statements regarding the occurrence of potential

hazards and side effects associated with the use of
the product and the limitation of its use.
 Contraindications

 Statements regarding the conditions wherein the use

of the product may cause harm to the patient.
 Precautions

 The instruction and special care required in the use

of the product to avoid undesired effects and to
ensure the safe and effective use of the drug.
 Date of manufacture

 For products other than biological products means

the date (month and year) during w/c processing of
the bulk product, from w/c the goods are to be filled,
is completed.
 Batch number

 Any distinctive combination of letters and/ or

numbers, assigned to a particular batch herein
defined as any product produced during a given cycle
of manufacture.
 The batch number permits the production history of
the batch including all stages of manufacture and
control, to be traced and reviewed.

 E.g. 01GRP1; 02GRP1; 03GRP1

 Expiration or expiry date

 The date after the product is not expected to retain

its claimed safety, efficacy and quality or potency or
after w/c it is not permissible to sell, distribute or use
the said product.
 Net Content

 The total amount/ quantity/ number of the dosage

form in a certain container of a product expressed in
metric system.
 Storage Condition

 The prevailing specified range temperature,

humidity and other environmental factors w/in w/c
optimal stability of the product is ensured based on
laboratory data.
 Principal display panel

 The part of a label that is most likely to be displayed,

presented, shown or examined under customary
condition of display for retail use.
 Area of the principal display panel

 The area or surface of the container/ package where

the principal display panel is located.
 Primary pack

 The 1st pack containing the individually wrapped

products, strip blister packs.
General Requirements
 Minimum mandatory information that shall be
included in the labelling materials:
 Name of the product (Generic  Contraindication/s,
name alone or w/ Brand precaution/s, warning/s
name, as the case may be)  Mode of administration/
 Dosage form and strength directions for use.
 Pharmacologic category  Batch and lot number
 Rx symbol, in case of  Expiry/ expiration date and
prescription drugs date of manufacture
 Name and complete address  Registration number
of manufacturer and trader,  Storage conditions
when applicable.  (For Rx products) Foods,
 Net content drugs and devices and
 Formulation Cosmetics Act prohibits
 Indications dispensing w/o prescription.
 All information required to appear on the label
must be:

 Written in English or Filipino

 Clearly and prominently displayed
 Readable w/ normal vision w/o straining.
 The color contrast, the position and spacing of the
information must be taken into consideration in
complying w/ labelling requirements.
 The principal display panel must:

 Contain the particulars required under the minimum

mandatory information that should be included in
labelling materials. (Name, dosage form and strength,
Pharmacologic category, Rx symbol, Name and address
of manuf, Net content)
 Comprises 40% of the total surface of the container,
except in the case of the rectangular container where the
total area of the principal display panel must equal to the
product of the height and width of the entire side of the
container.
 For any other shaped container presenting an obvious principal
display panel such as the top of a triangular or circular container, the
size of the area shall consist of the entire top surface.
 Label of the immediate container outside of the
principal display panel:

 Formulation
 Indication/s
 Mode of administration/ directions for use
 Batch and lot number
 Expiry/ expiration date and date of manufacture
 Registration number
 Storage conditions
 (For Rx) Foods, Drugs and Devices and Cosmetic Act
prohibits dispensing w/o prescription.
 Other info and additional detail shall appear on the other
labelling materials such as inserts/ leaflets or wrapper
cartons.
Specific Requirements
 Name of the product

 Generic name
 shall be the prominently printed element on the label, the
one with the highest point size among the various printed
elements on the label.
 Enclosed exclusively by an outline box rendered in the
same color as the generic name.
 Background color inside the box, against the generic name
is rendered, should be the same color as the background color
outside the box, against the brand name is rendered.
 Shall be printed in full, NOT abbreviated and in
accordance w/ the International Non-proprietary (INN). The
salt should be included inside the box but in smaller point
size.
 Name of the product

 Brand name together w/ its generic name:

 The generic name and brand name shall be rendered using the
same typeface, font and color, the generic name
appearing immediately above the brand name and rendered in
a point size bigger than the brand name.

 If a brand name is presented using a special typeface

exclusively designed and used for it, the generic name shall be
rendered in Helvetica Medium or Universe Medium
while complying w/ the other pertinent provisions above.
 Name of the product

 Products containing two (2) active ingredients shall

have the generic name of both active ingredients
indicated within the box for generic name.

 For products containing three (3) or more active

ingredients an official name for the combination, w/c
shall serve as the equivalent of the generic name,
shall be designated by a FDA committee experts.
 Dosage Form

 Shall be specified, such as tablets, capsules, syrups,

suspensions, ointments, including special delivery
system such as sustained release, etc.
 Pharmacologic Category

 Shall conform to the category used in the Philippine

National Drug Formulary attached as “Annex A”,
provided that drugs which cannot be classified under
this categories may be given a therapeutic category
other than what appears in the Annex subject to the
approval of FDA taking into consideration current
acceptable standards for therapeutic categories.
 Rx Symbol

 Must be printed in a contrasting color to the

background on w/c it appears.
 Over printing or superimposition of the Rx
symbol is allowed provided that such will not result
in obliterating or rendering less legible the other
required label requirements.
 Should be printed in a type size no less than one
fifth (1/5) of the height of the principal display
panel.
 Name and address of Manufacturer

 Must be complete and should also include the trader,

when applicable, must appear on the principal
display panel of the label.
 Net content

 Shall indicate the total amount/ quantity/

number of dosage form in a given container of the
product expressed in metric system.
 Formulation

 Active Ingredients (AI) must be stated in their generic

names (INN)
 The amounts of the AI shall be expressed in the metric
system or unit of potency, when applicable.
 Multiple components must be enumerated in the order of
decreasing pharmacologic activity, when applicable.
 The coloring agent and other excipients used in the
formulation that may cause hypersensitivity and/ or
other adverse reaction/s must be indicated.
 The alcohol content when present must be expressed
in percent (%).
 Indication

 Shall state only the approved clinical use/s of the

product as stated in the approved FDA registration.
 Contraindications, Precautions, Warnings

 Full information regarding contraindication/s to the

use of drugs, as well as precaution/s to be observed
in its administration and use must be provided.
 Warning statements, as required, and specified by
FDA must be stated.
 Mode of Administration/ Directions for use

 Full information must be provided for the

recommended dosage, including the initial dose, the
optimal use or usual dose, frequency interval, the
duration of treatment, dosage adjustment or other
pertinent aspects of drug therapy.
 Relevant information regarding dilution,
reconstitution, preparation and administration must
be included.
 Separate directions for adults and children, must be
stated, and if not recommended for the children, the
dosage shall be clearly identified as “adult dose”
 Batch/ Lot number

 If the entire batch is marketed under one company,

only the batch number needs to be indicated.
 If a batch is divided into several lots are marketed by
different companies, the lot number and its
corresponding batch number shall be indicated for
every lot.
 The batch and/ or lot number must be printed on
each strip of ten(10) blister units.
 Expiry/ Expiration Date

 The expiry or expiration date shall be expressed in

terms of the month and the year. In such cases, the
last day of the month is assumed as the expiration
date.
 For a drug that is reconstituted prior to use, a period
of guaranteed efficacy must be specified at a given
storage condition.
 The expiration date shall be printed or embossed on
the tin foil, blister and/ or strop package.
 Other additional specific info required

 Registration number shall indicate the drug

registration number and code assigned by FDA.

 Storage conditions appropriate for the product must

be stated.
 Summary

 In pursuant to the “Foods, Drugs and Devices, and

Cosmetics Act” and the “Generics Act of 1988”, it is
required that the generic name shall be the one
with the highest point size among the printed
elements of the label, printed in full and enclosed
exclusively by an outlined box. If the product is
identified by a brand name shall be one point size
bigger but in the same typeface, font and color as the
brand name and shall appear immediately above the
latter.