MAX NON ASPIRIN (ACETAMINOPHEN) TABLET [PROVISION MEDICAL PRODUCTS]

MAX NON ASPIRIN (ACETAMINOPHEN) TABLET [PROVISION MEDICAL PRODUCTS]
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NDC 69103-2522-5, 69103-2522-6
Set ID 6ee3c4e0-325a-426c-b694-0cdbe5aab188
Category HUMAN OTC DRUG LABEL
Packager Provision Medical Products
Generic Name
Product Class
Product Number
Application Number PART343
  • INDICATIONS & USAGE

    Uses: For the temporary relief of minor aches and pains associated with: • headache • common cold • toothache • minor arthritis pains • muscular aches • menstrual cramps • For the reduction of fever

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional

    before us

  • 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:

    Alcohol Warning: If you consume 3 or more alcoholic

    drinks every day, ask your doctor whether you should

    take acetaminophen or other pain relievers/fever

    reducers. Acetaminophen may cause liver damage.

    Do not use:

    with any other product containing acetaminophen

    for more than 10 days for pain unless directed

    by a doctor

    for more than 3 days for fever unless directed

    by a doctor

    Stop using and ask a doctor if:

    symptoms do not improve

    new symptoms occur

    pain or fever persists or gets worse

    redness or swelling is present

    Do not exceed recommended dosage

  • DOSAGE & ADMINISTRATION

    Directions:

    Do not use more than directed

    Adults and children 12 years and older take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours, or as directed by a doctor.

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

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    povidone, sodium starch glycolate,

    starch and stearic acid.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT-ACETAMINOPHEN 500 MG

  • PURPOSE

    PAIN RELIEVER/FEVER REDUCER

  • PRINCIPAL DISPLAY PANEL

    NON ASPRIN BOX

  • INGREDIENTS AND APPEARANCE
    MAX NON ASPIRIN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2522
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (SNOW WHITE) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-2522-5250 in 1 CARTON03/31/2015
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69103-2522-6100 in 1 CARTON03/31/2015
    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(69103-2522)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(69103-2522)

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