PAIN RELIEF ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [RITE AID CORPORATION]

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PAIN RELIEF ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [RITE AID CORPORATION]
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NDC 11822-0600-3, 11822-0600-4
Set ID 503408ed-e799-48a0-8d38-3034f4a0ead5
Category HUMAN OTC DRUG LABEL
Packager Rite Aid Corporation
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each tablet)

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

  • Purpose

    Pain reliever

  • 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.

  • 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

    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • are age 60 or older
    • 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
    • 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 have high blood pressure, heart disease, liver cirrhosis or kidney disease
    • you have asthma
    • you are taking a diuretic

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

  • 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
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • 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

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

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

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

    NDC 11822-0600-4

    LOW DOSE PAIN RELIEF
    ASPIRIN
    ASPIRIN 81 mg
    PAIN RELIEVER (NSAID)

    Aspirin regimen
    Safety coated

    ACTUAL
    SIZE

    500
    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 AG, owner of the registered trademark Bayer®
    Low Dose Aspirin.
    50844           REV0318D60014

    DISTRIBUTED BY: RITE AID
    30 HUNTER LANE,
    CAMP HILL, PA 17011

    www.riteaid.com

    SATISFACTION GUARANTEE:
    If you're not satisfied,
    we'll happily refund your money.

    Rite Aid 44-600A

    Rite Aid 44-600A

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF ASPIRIN  LOW DOSE
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0600
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0600-31 in 1 CARTON02/12/2008
    1120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11822-0600-61 in 1 CARTON02/12/2008
    2200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:11822-0600-4500 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2008
    4NDC:11822-0600-7300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/12/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/12/2008
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(11822-0600)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(11822-0600) , pack(11822-0600)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(11822-0600)
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