Label: SP PHARMA- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70875-500-01, 70875-500-02, 70875-500-03, 70875-500-04, view more70875-500-05 - Packager: Simpor Pharma Sdn Bhd
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 30, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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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
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SP PHARMA
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70875-500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 583 mg Inactive Ingredients Ingredient Name Strength STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score no score Shape ROUND Size 13mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70875-500-02 200 in 1 BOTTLE 08/01/2016 1 NDC:70875-500-01 500 mg in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:70875-500-04 20 in 1 CARTON 08/01/2016 2 NDC:70875-500-03 1500 mg in 1 DOSE PACK; Type 0: Not a Combination Product 3 NDC:70875-500-05 30 in 1 CARTON 08/01/2016 3 NDC:70875-500-03 1500 mg in 1 DOSE PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/01/2016 Labeler - Simpor Pharma Sdn Bhd (586043981) Establishment Name Address ID/FEI Business Operations Simpor Pharma Sdn Bhd 586043981 manufacture(70875-500)
