A.O No. 85 s.

1990
Subject: REQUIRMENTS FOR LABELING MATERIALS OF
CERTAIN CATEGORIES OF PRODUCT CONTANING TWO OR
MORE ACTIVE INGREDIENTS.

Presented by: MAGLINTE, LORDJAY LIZA E. – BSPH3

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Section 1: Applicability of the provision of A.O No.
55 s. 1988

All pertinent provision of A.O 55 s. 1988

on general requirements and specific
requirements for labeling materials of
pharmaceutical products.
 Section 1
example:

Sulfamethoxazole +
trimethoprim
 Section 2: Coverage
2.1 Products containing 2 to more
active ingredients with a single
international Non-propriety
name.
2.2 Products containing two and
three active ingredients but
without a single INN.
2.3 Fluid replacement and special
solution which follow the
standard formulations contained
in the current edition of the
Philippines National drug
formulary (PNDF)
2.4 Multivitamins product
which follow the standard
formulations contained in
the current edition of the
PNDF.
2.5 Multivitamins product
with non-vitamin
components which follow
the standard formulations
contained in the current
edition of the PNDF.
Section 3: Generic labeling

INN name of the combination product:

COTRIMOXAZOLE
Standard formulation of :
Sulfamethoxazole + trimethoprim

3.1 Official name of

products containing
two or
more active
ingredients with a
single INN.
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 3.2 Official name of product
containing two and three active
ingredients but without INN

PARACETAMOL
TRIPROLIDINE HCL
PSEUDOEPHEDRINE HCL
( Brand name, if any)

FERROUS SULFATE +
FOLIC acid
(Brand name, if any)

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 3.3 Official name of fluid
replacement and special
solution product which follow
the standard formulation
contained in the current edition
of the PNDF.
3.4 Official name of Multivitamins
products

Multi-Vitamins
A,B complex, C, D ,E

Brand Name, if any

3.5 official name of product containing other
Multivitamins standard formulations
3.6 Official name of Multivitamins Product with Non-
Vitamin component

Multi-Vitamins + Fe
A, B complex, C,D,E + Fe

Brand Name, if any

Multi-Vitamins + Minerals
A, B, Complex, C, D, E + Fe, Ca, P , Mn, Zn

Brand Name, if any

 A.O No. : 85 s. 1990

TITLE: Requirements for labeling materials of certain

categories of products containing two or more active
ingredients

DATE APPROVED: February 15, 1990

PRESIDENT WHO SIGNED THE LAW:

Corazon C. Aquino