Label: ENTERIC SAFETY COATED ASPIRIN- aspirin tablet, coated 

  • NDC Code(s): 11822-0899-1, 11822-0899-4, 11822-0899-6
  • Packager: Rite Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

    temporarily relieves minor aches and pains

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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
    • shock
    • facial swelling
    • 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
    • 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 have ever had an allergic reaction to any pain reliever or 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 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

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
    • and allergic reaction occurs
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present

    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 prblems 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.

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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 while symptoms persist. Do not exceed 48 tablets in 24 hours or as 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)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, 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

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    RITE AID®
    PHARMACY

    **Compare to the Active Ingredient in St. Josephs® Adult Low Strength Aspirn

    LOW DOSE
    pain relief
    aspirin
    aspirin 81 mg
    pain reliever (NSAID)

    adult low dose aspirin regimen

    safety coated

    200 ENTERIC COATED TABLETS

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark St. Josephs® Adult Low Strength Aspirn.

    50844       REV0512A41406

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

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

    Rite Aid 44-414A

    Rite Aid 44-414A

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  • INGREDIENTS AND APPEARANCE
    ENTERIC SAFETY COATED ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0899
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    Polyvinyl Acetate Phthalate  
    DIMETHICONE  
    SODIUM ALGINATE  
    SODIUM BICARBONATE  
    TALC  
    TITANIUM DIOXIDE  
    TRIACETIN  
    TRIETHYL CITRATE  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 44;414
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0899-1 1 in 1 CARTON
    1 180 in 1 BOTTLE, PLASTIC
    2 NDC:11822-0899-6 1 in 1 CARTON
    2 200 in 1 BOTTLE, PLASTIC
    3 NDC:11822-0899-4 500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 01/14/2004
    Labeler - Rite Aid (014578892)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11822-0899)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11822-0899)
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