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 11822-6451-4, 11822-6451-6
Set ID df7835c9-f10f-40c6-8955-61423d94b677
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:

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

    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
      • have bloody or black stools
      • feel faint
      • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    colloidal anhydrous silica, corn starch, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, 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 you heart.

    NDC 11822-6451-4

    Compare to the active ingredient in St. Joseph®
    Low Dose Safety Coated 81 mg Aspirin**

    LOW DOSE PAIN RELIEF
    ASPIRIN
    ASPIRIN 81 mg

    PAIN RELIEVER (NSAID)

    Aspirin regimen

    Safety coated

    ACTUAL SIZE

    500
    ENTERIC
    COATED TABLETS

    NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

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

    **This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, owner of the registered trademark St. Joseph® Low Dose Safety
    Coated 81 mg Aspirin.    

    50844       REV0318C64514

    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 44-645

    Rite Aid 44-645

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF ASPIRIN  LOW DOSE
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6451
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-6451-61 in 1 CARTON07/25/201401/07/2022
    1200 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11822-6451-4500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/25/2014
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(11822-6451)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(11822-6451) , pack(11822-6451)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(11822-6451)
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