Otc - Active Ingredient
ACTIVE INGREDIENTS:
Paracetamol 500 mg
Sp Pharma
FDA Label NDC 70875-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Simpor Pharma Sdn Bhd for the product Sp Pharma (NDC 70875-500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, indications & usage, dosage & administration, inactive ingredient, storage and handling, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Image Description (Para 200)
Image Description (Para 30)
Image Description (Para Box)
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