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

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 healthcare professional or from the pharmaceutical industry please visit this version.

  • INDICATIONS & USAGE

    Uses:

    for temporary relief of mild to moderate pain

    associated with headache.

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  • 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.

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  • 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.

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  • 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

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  • 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.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    cellulose, pharmaceutical glaze,

    povidone, starch, stearic acid and talc

    USP.

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  • ACTIVE INGREDIENT

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

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  • PURPOSE

    PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT

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  • INGREDIENTS AND APPEARANCE
    PAIN TERMINATOR 2 SEVERE 
    aspirin, acetaminophen, caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69103-2533
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white (SNOW WHITE) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code FR9
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69103-2533-5 250 in 1 CARTON 04/03/2015
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:69103-2533-6 100 in 1 CARTON 04/03/2015
    2 2 in 1 PACKET; 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 04/03/2015
    Labeler - Provision Medical Products (036936831)
    Registrant - Provision Medical Products (036936831)
    Establishment
    Name Address ID/FEI Business Operations
    Ultraseal Corporation 085752004 pack(69103-2533)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(69103-2533)
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