SP PHARMA- acetaminophen tablet 
Simpor Pharma Sdn Bhd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS:

Paracetamol 500 mg

PARACETAMOL TABLETS ARE USED FOR:

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

Fever, Feverish Colds

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

PARACETAMOL TABLETS ARE USED FOR:

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

Fever, Feverish Colds

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 INGREDIENTS:

Pregelatinized Starch, Povidone, Magnesium Stearate,

Sodium Starch Glycolate

STORAGE CONDITION

STORE BELOW 25C. 

KEEP AWAY FROM CHILDREN

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SP PHARMA 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70875-500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 583 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70875-500-02200 in 1 BOTTLE08/01/2016
1NDC:70875-500-01500 mg in 1 PACKAGE; Type 0: Not a Combination Product
2NDC:70875-500-0420 in 1 CARTON08/01/2016
2NDC:70875-500-031500 mg in 1 DOSE PACK; Type 0: Not a Combination Product
3NDC:70875-500-0530 in 1 CARTON08/01/2016
3NDC:70875-500-031500 mg in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/01/2016
Labeler - Simpor Pharma Sdn Bhd (586043981)
Establishment
NameAddressID/FEIBusiness Operations
Simpor Pharma Sdn Bhd586043981manufacture(70875-500)

Revised: 1/2019
Document Id: 80ad573e-6009-f4ee-e053-2991aa0aa976
Set id: bd85912e-23bf-499f-b91d-7ff17f61c8df
Version: 2
Effective Time: 20190130
 
Simpor Pharma Sdn Bhd