SP Pharma

Manufacturer: Simpor Pharma Sdn Bhd
Effective date: 2019-01-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:58:23

Label at a glance#

ProductSP Pharma

Active ingredientACETAMINOPHEN

Label structure11 sections

Storage and handling

STORAGE CONDITION STORE BELOW 25C.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

Paracetamol 500 mg

OTC - PURPOSE SECTION

PARACETAMOL TABLETS ARE USED FOR:

Headache, Toothache, Sore Throat, Backache, Period Pain,

Fever, Feverish Colds

WARNINGS SECTION

CHECK WITH YOUR DOCTOR BEFORE TAKING PARACETAMOL

TABLETS IF YOU:

-Have liver or kidney problems

-Are taking warfarin or toehr blood thinning medications

DO NOT TAKE:

-If you are allergic to paracetamol

-If you are taking other medicines containing paracetamol

This preparation may not be suitable for children below 6

years of age.

IF SYMPTOMS PERSIST FOR MORE THAN 48 HOURS OR IF

YOU HAVE ANY OF THE FOLLOWING SERIOUS EFFECTS:

-Allergic skin reaction -Shortness of Breath -Wheezing

STOP TAKING THIS MEDICATION AND CONTACT YOUR

DOCTOR

INDICATIONS & USAGE SECTION

PARACETAMOL TABLETS ARE USED FOR:

Headache, Toothache, Sore Throat, Backache, Period Pain,

Fever, Feverish Colds

DOSAGE & ADMINISTRATION SECTION

12 years - Adults

Take 1 -2 tablets every 4 - 6 hours with

water as required (maximum 8 tablets in 24

hours)

6-11 years

Take 1 tablet every 4 - 6 hours with water

as required (maximum 4 tablets in 24 hours)

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Pregelatinized Starch, Povidone, Magnesium Stearate,

Sodium Starch Glycolate

STORAGE AND HANDLING SECTION

STORAGE CONDITION

STORE BELOW 25C.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP AWAY FROM CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	2
198440	acetaminophen 500 MG Oral Tablet	SCD	2
198440	APAP 500 MG Oral Tablet	SY	2

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	6234000011191	GTIN-13: 6234000011191 EAN-13: 6234000011191 GTIN storage (14 digits): 06234000011191	Para_200.jpg
Barcode	EAN-13	6234000011214	GTIN-13: 6234000011214 EAN-13: 6234000011214 GTIN storage (14 digits): 06234000011214	Para_30.jpg
Barcode	EAN-13	6234000011245	GTIN-13: 6234000011245 EAN-13: 6234000011245 GTIN storage (14 digits): 06234000011245	Para_box.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70875-500-02	2023-01-30	C162847	48780-1	f386c64a-1be5-0266-e053-dadaa90a7c1a	bd85912e-23bf-499f-b91d-7ff17f61c8df
70875-500-04	2023-01-30	C162847	48780-1	f386c64a-1be5-0266-e053-dadaa90a7c1a	bd85912e-23bf-499f-b91d-7ff17f61c8df
70875-500-05	2023-01-30	C162847	48780-1	f386c64a-1be5-0266-e053-dadaa90a7c1a	bd85912e-23bf-499f-b91d-7ff17f61c8df

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70875-500-01	SP Pharma	500 mg in 1 PACKAGE	TABLET	500	2
70875-500-02	SP Pharma	200 in 1 BOTTLE	TABLET	200	2
70875-500-03	SP Pharma	1500 mg in 1 DOSE PACK	TABLET	1500	2
70875-500-04	SP Pharma	20 in 1 CARTON	TABLET	20	2
70875-500-05	SP Pharma	30 in 1 CARTON	TABLET	30	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70875-500	SP PHARMA (ACETAMINOPHEN) TABLET [SIMPOR PHARMA SDN BHD]	2	Legacy NDC, 5 package rows	20190130_bd85912e-23bf-499f-b91d-7ff17f61c8df.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

SP Pharma
ACETAMINOPHEN
STARCH, PREGELATINIZED CORN
POVIDONE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70875-500	70875-500-01, 70875-500-02, 70875-500-03, 70875-500-04, 70875-500-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STARCH, PREGELATINIZED CORN	O8232NY3SJ	IACT
POVIDONE	FZ989GH94E	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
80ad573e-6009-f4ee-e053-2991aa0aa976			bd85912e-23bf-499f-b91d-7ff17f61c8df	2019-01-30	Warnings	Exact identifier spl id: 80ad573e-6009-f4ee-e053-2991aa0aa976 spl set id: bd85912e-23bf-499f-b91d-7ff17f61c8df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.