SP PHARMA- acetaminophen tablet Simpor Pharma Sdn BhdDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply 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

SP PHARMA acetaminophen tablet

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:70 8 75-50 0

Route of Adminis tration ORAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 50 0 mg in 58 3 mg

Inactive IngredientsIngredient Name Strength

STARCH, PREGELATINIZED CO RN (UNII: O8 232NY3SJ)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

Product CharacteristicsColor white Score no sco re

Simpor Pharma Sdn Bhd

Shape ROUND Siz e 13mm

Flavor Imprint Code

Contains

Packaging

# Item Code Package Description Marketing StartDate

Marketing EndDate

1 NDC:70 8 75-50 0 -0 2 20 0 in 1 BOTTLE 0 8 /0 1/20 16

1 NDC:70 8 75-50 0 -0 1 50 0 mg in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

2 NDC:70 8 75-50 0 -0 4 20 in 1 CARTON 0 8 /0 1/20 16

2 NDC:70 8 75-50 0 -0 3

150 0 mg in 1 DOSE PACK; Type 0 : No t a Co mbinatio nPro duct

3 NDC:70 8 75-50 0 -0 5 30 in 1 CARTON 0 8 /0 1/20 16

3 NDC:70 8 75-50 0 -0 3

150 0 mg in 1 DOSE PACK; Type 0 : No t a Co mbinatio nPro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph no t fina l part343 0 8 /0 1/20 16

Labeler - Simpor Pharma Sdn Bhd (586043981)

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

Simpo r Pharma Sdn Bhd 58 6 0 439 8 1 manufacture(70 8 75-50 0 )

Revised: 1/2019