Label: ZEE ASPIRIN- aspirin tablet

  • NDC Code(s): 35418-232-02, 35418-232-67, 35418-232-68, 35418-232-70
  • Packager: Zee Medical Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 January 14, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient/Tablet Aspirin 325 mg

    Close
  • PURPOSE

    Purpose-Pain Reliever/Fever Reducer

    Close
  • INDICATIONS & USAGE

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

    Close
  • DOSAGE & ADMINISTRATION

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

    Children under 12 years, ask a doctor


    Close
  • 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

    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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.

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredients: corn starch, microcrystalline cellulose,  
    povidone, 

    Close
  • PRINCIPAL DISPLAY PANEL

    MMAspirin, 250 Box

    second box label1

    Close
  • INGREDIENTS AND APPEARANCE
    ZEE ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-232
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    Product Characteristics
    Color white (snow white) Score no score
    Shape ROUND ( FR21) Size 10mm
    Flavor Imprint Code FR21
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35418-232-68 50 in 1 CARTON
    1 NDC:35418-232-67 125 in 1 CARTON
    1 NDC:35418-232-02 2 in 1 PACKET
    2 NDC:35418-232-70 24 in 1 BOX
    2 NDC:35418-232-67 125 in 1 CARTON
    2 NDC:35418-232-02 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(35418-232)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(35418-232)
    Close