Label: ASPIRIN LOW DOSE- aspirin tablet, coated

  • NDC Code(s): 55315-600-17, 55315-600-32
  • Packager: FRED'S, 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 December 7, 2018

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug 

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  • Purpose

    Pain reliever 

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  • Uses

    for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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

    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

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • 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:
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
      • feel faint
    • ringing in the ears or a loss of hearing occurs
    • pain gets worse or lasts more than 10 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 4 to 8 tablets every 4 hours not to exceed 48 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

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

    corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate 

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    fred's
    Pharmacy

    NDC 55315-600-17

    Compare to the active ingredient in:
    Bayer® Low Dose Aspirin

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

    Low Dose
    Aspirin      81 mg each

    Pain Reliever (NSAID)

    • Aspirin Regimen
    • Safety Coated

    NOT FOR HOUSEHOLDS
    WITH YOUNG CHILDREN

    300 ENTERIC
    COATED TABLETS

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

    This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Bayer® Low Dose Aspirin.
    50844        REV0318B60017

    DISTRIBUTED BY: fred's, Inc.
    4300 NEW GETWELL RD, MEMPHIS, TN 38118
    www.fredsinc.com

    100% satisfaction guaranteed
    Questions or comments:
    1-855-331-FRED (3733)

    Freds 44-600A

    Freds 44-600A


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  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-600
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code L
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-600-32 1 in 1 CARTON 05/01/2011
    1 120 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:55315-600-17 300 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/01/2011
    Labeler - FRED'S, INC. (005866116)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55315-600)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 MANUFACTURE(55315-600) , PACK(55315-600)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(55315-600)
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