PAIN TERMINATOR (ASPIRIN, ACETAMINOPHEN, CAFFEINE, SALICYLAMIDE) TABLET [PROVISION MEDICAL PRODUCTS]

PAIN TERMINATOR (ASPIRIN, ACETAMINOPHEN, CAFFEINE, SALICYLAMIDE) TABLET [PROVISION MEDICAL PRODUCTS]
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NDC 69103-2507-5, 69103-2507-6
Set ID 54b10f1d-8988-4f2f-88f8-49ee9d2cb96e
Category HUMAN OTC DRUG LABEL
Packager Provision Medical Products
Generic Name
Product Class
Product Number
Application Number PART343
  • 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)

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