Label: PAIN TERMINATOR 2 SEVERE- aspirin, acetaminophen, caffeine tablet

  • NDC Code(s): 69103-2533-5, 69103-2533-6
  • Packager: Provision Medical Products
  • 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 April 4, 2015

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    Uses:

    for temporary relief of mild to moderate pain

    associated with headache.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a

    health professional before use. IT IS

    ESPECIALLY IMPORTANT NOT TO USE

    ASPIRIN DURING THE LAST 3 MONTHS

    OF PREGNANCY UNLESS SPECIFICALLY

    DIRECTED TO DO SO BY A DOCTOR,

    BECAUSE IT MAY CAUSE PROBLEMS IN

    THE UNBORN CHILD OR

    COMPLICATIONS DURING DELIVERY.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In

    case of overdose, get medical help or

    contact a Poison Control Center right

    away. Prompt medical attention is

    critical for adults as well as for children

    even if you do not notice any signs or

    symptoms.

  • WARNINGS

    Warnings:

    Reye's syndrome: Children and teenagers should not

    use this medicine for chicken pox or  u symptoms

    before a doctor is consulted about Reye's syndrome, a

    rare but serious illness reported to be associated with

    aspirin.

    Allergy Alert: Do not take this product if after

    taking a pain reliever or fever reducer you ever had • hives • facial swelling • asthma • shock

    Alcohol Warning: If you consume 3 or more

    alcoholic drinks every day, ask your doctor whether you

    should take acetaminophen and aspirin or other pain

    relievers/fever reducers. Acetaminophen and aspirin may

    cause liver damage and stomach bleeding.

    Ask a doctor before use if you have: • the worst headache of your life • ulcers

    • fever and sti neck • asthma

    • bleeding problems • liver disease

    • renal disease

    When using this product:

    • limit the use of caffeine containing medications,

    foods, or beverages while taking this product

    because too much caFFeine may cause

    nervousness, sleeplessness, irritability and,

    occasionally, rapid heart beat.

    Stop use and ask a doctor if:

    • headache pain worsens or continues for more than 48 hours

    • new or unexpected symptoms occur

    • ringing in the ears or loss of hearing occur

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age, no to exceed 8 tablets in 24 hours, or as directed by a doctor.

    Children under 12 years: Do not give to children under 12 unless directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    cellulose, pharmaceutical glaze,

    povidone, starch, stearic acid and talc

    USP.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT-ACETAMINOPHEN 250 MG, ASPIRIN 250 MG,CAFFEINE 65 mg

  • PURPOSE

    PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT

  • PRINCIPAL DISPLAY PANEL

    PAIN TERMINATOR SEVERE BOX

  • INGREDIENTS AND APPEARANCE
    PAIN TERMINATOR 2 SEVERE 
    aspirin, acetaminophen, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2533
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    CAFFEINE (UNII: 3G6A5W338E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    Colorwhite (SNOW WHITE) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-2533-5250 in 1 CARTON04/03/2015
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69103-2533-6100 in 1 CARTON04/03/2015
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/03/2015
    Labeler - Provision Medical Products (036936831)
    Registrant - Provision Medical Products (036936831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultraseal Corporation085752004pack(69103-2533)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(69103-2533)