Label: PAIN TERMINATOR- aspirin, acetaminophen, caffeine, salicylamide tablet

  • NDC Code(s): 69103-2507-5, 69103-2507-6
  • 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 3, 2015

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  • INDICATIONS & USAGE

    Uses:

    temporarily relieves minor aches and pains

    associated with: • backache • toothache • colds • headaches • muscular aches • menstrual cramps • minor arthritis pain

  • 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.

    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.

    Do not use:• if you are allergic to aspirin • with any other pain reliever/fever reducer • if you have ever had an allergic reaction to any

    other pain reliever/fever reducer

    • for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor

    • with any other product containing acetaminophen

    Ask a doctor before using if you have:

    • asthma • gastric ulcers • bleeding problems • stomach problems (such as heartburn, upset stomach or stomach pain)

    Ask a doctor or pharmacist before use if you are taking a prescription drug for: • anticoagulation (thinning of blood)

    • diabetes • gout • arthritis

    Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse

    • new symptoms occur • redness or swelling is present

    When using this product do not exceed

    recommended dose.

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and older take 2 tablets

    every 4 hours  for pain as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

    Children under 12 years consult a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    FD&C yellow #6, magnesium stearate,

    microcrystalline cellulose, povidone,

    starch, and stearic acid.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT-ACETAMINOPHEN 110 MG, ASPIRIN 162 MG,CAFFEINE 32.4MG, SALICYLAMIDE  152 MG

  • PURPOSE

    PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN TERMINATOR 
    aspirin, acetaminophen, caffeine, salicylamide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2507
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
    SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
    Inactive Ingredients
    Ingredient NameStrength
    CAFFEINE (UNII: 3G6A5W338E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorblue (SKY BLUE) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-2507-5250 in 1 CARTON04/03/2015
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69103-2507-6100 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 finalpart34303/31/2015
    Labeler - Provision Medical Products (036936831)
    Registrant - Provision Medical Products (036936831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultraseal Corporation085752004pack(69103-2507)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(69103-2507)