storage condition - dailymed.nlm.nih.gov
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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