Label: NORTH ASPIRIN- aspirin tablet

  • NDC Code(s): 0498-0113-01, 0498-0113-05, 0498-0113-10, 0498-0113-25, view more
    0498-0113-50, 0498-0114-01, 0498-0114-05, 0498-0114-10, 0498-0114-25, 0498-0114-50
  • Packager: Honeywell Safety Products USA, 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 September 18, 2018

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

  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Uses:

    temporarily reduces fever and relieves minor aches and pains associated with:

    • a cold
    • headache
    • toothache
    • muscular aches
    • backache
    • minor pain of arthritis
    • premenstrual and menstrual periods
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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 an 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 prescription 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 heartburn
    • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
    • you are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for diabetes, gout or arthritis

    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
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • ringing in the ears or loss of hearing occurs
    • any new symptoms appear

    If pregnant or breast-feeding,

    If pregnant or breat-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 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 of age and older: take 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
    • children under 12 years of age: consult a doctor
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  • Other information

    • store at room temperature 15° - 30°C (59° - 86°F)
    • TAMPER EVIDIENT PACKETS - DO NOT USE IF OPEN OR TORN
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  • Inactive ingredients

    corn starch, croscarmellose sodium*, hypromellose*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, propylene glycol, silicon dioxide, stearic acid*, titanium dioxide*

    *may contain these ingredients

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  • Questions or comments?

    1-800-430-5490

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  • Honeywell Aspirin
  • INGREDIENTS AND APPEARANCE
    NORTH ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-0113
    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
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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 11/07/2011 09/18/2018
    1 NDC:0498-0113-01 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:0498-0113-10 100 in 1 BOX, UNIT-DOSE 11/07/2011 09/18/2018
    2 NDC:0498-0113-01 2 in 1 PACKET; Type 0: Not a Combination Product
    3 NDC:0498-0113-25 250 in 1 BOX, UNIT-DOSE 11/07/2011 09/18/2018
    3 NDC:0498-0113-01 2 in 1 PACKET; Type 0: Not a Combination Product
    4 NDC:0498-0113-50 500 in 1 BOX, UNIT-DOSE 11/07/2011 09/18/2018
    4 NDC:0498-0113-01 2 in 1 PACKET; Type 0: Not a Combination Product
    5 NDC:0498-0113-01 2 in 1 PACKET; Type 0: Not a Combination Product 11/07/2011 09/18/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 11/07/2011 09/18/2018
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-0114
    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
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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:0498-0114-05 50 in 1 BOX 09/18/2018
    1 NDC:0498-0114-01 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:0498-0114-10 100 in 1 BOX 09/18/2018
    2 NDC:0498-0114-01 2 in 1 PACKET; Type 0: Not a Combination Product
    3 NDC:0498-0114-25 250 in 1 BOX 09/18/2018
    3 NDC:0498-0114-01 2 in 1 PACKET; Type 0: Not a Combination Product
    4 NDC:0498-0114-50 500 in 1 BOX 09/18/2018
    4 NDC:0498-0114-01 2 in 1 PACKET; Type 0: Not a Combination Product
    5 NDC:0498-0114-01 2 in 1 PACKET; Type 0: Not a Combination Product 09/18/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/18/2018
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc 079287321 repack(0498-0113, 0498-0114)
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