Label: SP PHARMA- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Paracetamol 500 mg

  • 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. 

  • KEEP OUT OF REACH OF CHILDREN

    KEEP AWAY FROM CHILDREN

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SP PHARMA 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70875-500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 583 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70875-500-02200 in 1 BOTTLE08/01/2016
    1NDC:70875-500-01500 mg in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:70875-500-0420 in 1 CARTON08/01/2016
    2NDC:70875-500-031500 mg in 1 DOSE PACK; Type 0: Not a Combination Product
    3NDC:70875-500-0530 in 1 CARTON08/01/2016
    3NDC:70875-500-031500 mg in 1 DOSE PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/01/2016
    Labeler - Simpor Pharma Sdn Bhd (586043981)
    Establishment
    NameAddressID/FEIBusiness Operations
    Simpor Pharma Sdn Bhd586043981manufacture(70875-500)
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