Label: NORTH ASPIRIN  - aspirin tablet 

  • Label RSS
  • NDC Code(s): 0498-0113-01, 0498-0113-05, 0498-0113-10, 0498-0113-25, view more
    0498-0113-50
  • Packager: North Safety Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • Active ingredient

    Aspirin 325 mg (NSAID)

    "nonsteroidal anti-inflammatory drug"

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    for the temporary relief of minor aches and pains associated with:

    • a cold
    • headache
    • toothache
    • muscular aches
    • backache - premenstrual and menstrual periods
    • minor pain from arthritis
    • and to reduce fever
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  • 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 a nonsteroidal anti-inflammatory drug (NSAID), 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 containing prescriptions or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • 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 heartburrn
    • high blood pressure
    • heart disease
    • liver cirrhosis
    • kidney disease or are taking a diuretic
    • ulcers
    • bleeding problems
    • reached age 60 or older
    • 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:

    you experience any of the following signs of stomach bleeding

    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better

    If pregnant or breast feeding

    ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of the reach of children

    In case of overdose, get medical help or  contact Poison Control Center right away.

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  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 or 2 tablets with water every 4 hours while symptoms persist.
    • not more than 12 tablets in 24 hours
    • children under 12 years: consult a doctor
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  • Other information

    • store at room temperature 15o - 30o C  (59o - 86o F)
    • tamper evident packets
    • do not use if open or torn
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  • Inactive ingredients

    corn starch, povidone, silicon dioxide, stearic acid

    * croscarmellose sodium, *hypromellose,* microcrystaline cellulose,*mineral oil, * polyethylene glycol

    *propylene glycol,* titanium dioxide, *contains one or more of these ingredients

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  • Questions or comments?

    1-800-430-4110

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    NORTH ASPIRIN  
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0498-0113
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (Aspirin) Aspirin 325 
    Inactive Ingredients
    Ingredient Name Strength
    CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED  
    CROSPOVIDONE  
    CHOLESTERYL STEARATE  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSE 2208 (100 MPA.S)  
    LIGHT MINERAL OIL  
    CELLULOSE, MICROCRYSTALLINE  
    CHOLETH-20  
    TITANIUM DIOXIDE  
    PROPYLENE GLYCOL  
    Product Characteristics
    Color white (White) Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code FR21
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0113-05 50 in 1 BOX, UNIT-DOSE
    1 2 in 1 PACKET
    2 NDC:0498-0113-10 100 in 1 BOX, UNIT-DOSE
    2 2 in 1 PACKET
    3 NDC:0498-0113-25 250 in 1 BOX, UNIT-DOSE
    3 2 in 1 PACKET
    4 NDC:0498-0113-50 500 in 1 BOX, UNIT-DOSE
    4 2 in 1 PACKET
    5 NDC:0498-0113-01 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 11/07/2011
    Labeler - North Safety Products (019777263)
    Establishment
    Name Address ID/FEI Business Operations
    North Safety Products 019777263 manufacture(0498-0113), pack(0498-0113)
    Establishment
    Name Address ID/FEI Business Operations
    UltraTab Laboratories 151051757 manufacture(0498-0113)
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