ZEE ASPIRIN (ASPIRIN) TABLET [ZEE MEDICAL INC]

ZEE ASPIRIN (ASPIRIN) TABLET [ZEE MEDICAL INC]
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NDC 35418-232-02, 35418-232-67, 35418-232-68, 35418-232-70
Set ID 6f474689-1275-4e98-b163-050786f5f46f
Category HUMAN OTC DRUG LABEL
Packager Zee Medical Inc
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Active Ingredient/Tablet Aspirin 325 mg

  • PURPOSE

    Purpose-Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    Temporarily relieves pain due to: headache, muscular aches, cold, minor pain of arthritis.  Temporarily reduces fever

  • DOSAGE & ADMINISTRATION

    Adults: Take 2 tablets every 4hours, not to exceed 12 caplets in 24 hours

    Children under 12 years, ask a doctor


  • WARNINGS

    Warnings:
    Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

    Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause stomach bleeding.

    The chance is higher if you:
    •    are age 60 or older
    •    have had stomach ulcers or bleeding problems
    •    take a blood thinning (anticoagulant) or steroid drug
    •    take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others.
    •    Take more or for a longer time than directed


    Allergy Alert-Do not use:
    •    if you are allergic to aspirin or any other salicylates
    •    If you have ever had an allergic reaction to any other pain reliever/fever reducer 


    Do not use:
    •    with any other pain reliever/fever reducer


    Ask doctor before using if you have:
    •    upset stomach or stomach pain
    •    ulcers
    •    bleeding problems
    •    high blood pressure
    •    heart or kidney disease
    •    taken a diuretic
    •    reached age 60 or older

    Ask a doctor or pharmacist before use if you are:
    •    taking any other drug containing an NSAID (prescription or nonprescription)
    •    taking a blood thinning (anticoagulant) or steroid drug

    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
    •    you feel faint, vomit blood, or have bloody or black stools.  These are signs of stomach bleeding

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional  
    before use

  • 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.

  • INACTIVE INGREDIENT

    Inactive Ingredients: corn starch, microcrystalline cellulose,  
    povidone, 

  • PRINCIPAL DISPLAY PANEL

    MMAspirin, 250 Box

    second box label1

  • INGREDIENTS AND APPEARANCE
    ZEE ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND ( FR21) Size10mm
    FlavorImprint Code FR21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35418-232-6850 in 1 CARTON06/12/2012
    1NDC:35418-232-67125 in 1 CARTON
    1NDC:35418-232-022 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:35418-232-7024 in 1 BOX06/12/2012
    2NDC:35418-232-67125 in 1 CARTON
    2NDC:35418-232-022 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultratab Laboratories, Inc.151051757manufacture(35418-232)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004repack(35418-232)

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