Label: ASPIRIN- aspirin tablet, film coated

  • NDC Code(s): 11868-157-12, 11868-157-17
  • Packager: New Genesis/Monticello Drug LLC
  • 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 24, 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 relieves:
      • minor pain of arthritis
      • headache
      • muscle pain
      • menstrual pain
      • toothache
      • pain and fever of colds
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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:

    • facial swelling
    • shock
    • hives
    • asthma (wheezing)

    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
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • take more or for a longer time than directed
    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    • you are taking a diuretic
    • 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 have asthma

    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:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 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 a Poison Control Center (1-800-222-1222) 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 every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years: do not use unless directed by a doctor
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  • Other information

    • use by expiration date on package
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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  • Inactive ingredients

    corn starch, hypromellose, polyethylene glycol, propylene glycol

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  • Principal display panel

    Family trusted for over 100 years

    Norwich®

    ASPIRIN
    Pain Reliever/Fever Reducer
    (NSAID) 325 mg per tablet

    Talk to your doctor or other healthcare provider before using this product for your heart.

    Regular Strength

    100 COATED TABLETS

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    50844 REV0318B15712

    Distributed by:
    New Genesis/Monticello Drug LLC
    Jacksonville, FL 32207
    www.newgenesismonticellodrug.com (904) 647-7825

    Norwich 44-157

    Norwich 44-157

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11868-157
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code ASPIRIN;44;157
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11868-157-12 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996
    2 NDC:11868-157-17 300 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 02/10/1996
    Labeler - New Genesis/Monticello Drug LLC (079396165)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 MANUFACTURE(11868-157)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(11868-157)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(11868-157)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11868-157)
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