FDA Label for Sp Pharma
View Indications, Usage & Precautions
Sp Pharma Product Label
The following document was submitted to the FDA by the labeler of this product Simpor Pharma Sdn Bhd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
ACTIVE INGREDIENTS:
Paracetamol 500 mg
Otc - Purpose
PARACETAMOL TABLETS ARE USED FOR:
Headache, Toothache, Sore Throat, Backache, Period Pain,
Fever, Feverish Colds
Warnings
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
PARACETAMOL TABLETS ARE USED FOR:
Headache, Toothache, Sore Throat, Backache, Period Pain,
Fever, Feverish Colds
Dosage & Administration
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
INACTIVE INGREDIENTS:
Pregelatinized Starch, Povidone, Magnesium Stearate,
Sodium Starch Glycolate
Storage And Handling
STORAGE CONDITION
STORE BELOW 25C.
Otc - Keep Out Of Reach Of Children
KEEP AWAY FROM CHILDREN
Package Label.Principal Display Panel
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