Label: ADVANCED ASPIRIN- aspirin tablet

  • NDC Code(s): 67060-232-02, 67060-232-68
  • Packager: ADVANCED FIRST AID, 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 April 7, 2015

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT IN EACH TABLET- ASPIRIN 325 MG

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  • PURPOSE

    PAIN RELIEVER/FEVER REDUCER

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  • INDICATIONS & USAGE

    Uses:

    temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis•

    muscle pain • pain and fever of colds • toothache • temporarily reduces fever

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  • WARNINGS

    Uses:

    temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis

    muscle pain • pain and fever of colds • toothache • temporarily reduces fever

    Warnings:

    Reye's syndrome:

    Children and teenagers who have or are recovering from chicken pox or flu-like

    symptoms should not use this product. When using this product, if changes in behavior with nausea and

    vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a

    rare but serious illness

    .

    Allergy Alert:

    Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling

    asthma (wheezing) • shock

    Stomach Bleeding Warning:

    This product contains nonsteroidal anti-inflammatory drugs (NSAIDs),

    which may cause severe 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 prescription or nonprescription containing an NSAID [aspirin, ibuprofen, naproxen, or

    others]

    • take more or for a longer time than directed.

    Do not use:

    • if you are allergic to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if:

    • stomach bleeding warning applies to you • you have a history of

    stomach problems, such as heartburn

    • you have high blood pressure, heart disease, liver cirrhosis, or

    kidney disease

    • you are taking a diuretic • you have a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for: • gout

    diabetes • arthritis

    Stop use and ask a doctor if:

    • an allergic reaction occurs. Seek medical help right away. • you

    experience any of the following signs of stomach bleeding:

    • you feel faint, vomit blood, or have bloody

    or black stools

    • redness or swelling is present • pain gets worse or lasts more than 10 days • fever lasts

    more than 3 days

    • new symptoms occur • ringing in the ears or a loss of hearing occurs

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby,

    ask a health professional

    before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN

    DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS

    SPECIFIC-ALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT

    MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR

    COMPLICATIONS DURING DELIVERY.

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions:

    Drink a full glass of water with each dose

    Adults and children 12 years OR OLDER :TAKE 2 TABLETS EVERY 4-6 HOURS AS needed, do not exceed 12 tablets in

    24 hours, or as directed by a doctor.

    Children under 12 YEARSOF AGE

    • consult a doctor

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    microcrystalline cellulose,

    povidone, pregelatinized starch

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  • INGREDIENTS AND APPEARANCE
    ADVANCED ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-232
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white (SNOW WHITE) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code FR21
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67060-232-68 100 in 1 CARTON 04/07/2015
    1 NDC:67060-232-02 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/07/2015
    Labeler - ADVANCED FIRST AID, INC. (114477180)
    Registrant - ADVANCED FIRST AID, INC. (114477180)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRA SEAL CORPORATION 085752004 pack(67060-232)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-232)
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