Label: REGULAR STRENGTH ENTERIC COATED ASPIRIN  - aspirin tablet, coated 

  • NDC Code(s): 57896-921-01, 57896-921-10, 57896-921-25, 57896-921-50
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 11/12

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

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  • Uses

    • for the temporary relief of minor aches and pains
    • ask your doctor about other uses for aspirin
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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
    • asthma (wheezing)
    • shock
    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 are allergic to aspirin or any other pain reliever/fever reducer.

    Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you are taking a diuretic
    • you have a history of stomach problems, such as heartburn
    • you have: -high blood pressure -heart disease -liver cirrhosis  -kidney disease -asthma

    Ask a doctor or pharmacist before use if you are

    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid drug
    • taking a prescription drug for diabetes, gout or arthritis

    Stop use and ask a doctor if

    • 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
    • an allergic reaction occurs. Seek medical help right away
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • fever gets worse or lasts more than 3 days
    • any new symptoms occur
    • ringing in the ears or loss of hearing occurs
    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.

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  • Directions

    • drink a full glass of water with each dose
    • swallow whole, do not chew or crush
    • do not exceed recommended dose
    • adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
    • children under 12 years: ask a doctor
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  • Other information

    • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
    • for institutional use only
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  • Inactive ingredients

    cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, shellac wax, silica, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose phthalate, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.

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  • package label

    GERICARE
    NDC 57896-921-01
    Regular Strength
    ENTERIC COATED  ASPIRIN
    pain reliever (NSAID)
    PACKAGE NOT CHILD RESISTANT
    100 Tablets
    325 mg each
    Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

    rs enteric coated aspirin label

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  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH ENTERIC COATED ASPIRIN  
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57896-921
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE  
    STARCH, CORN  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    POLYVINYL ACETATE PHTHALATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    SHELLAC  
    SILICON DIOXIDE  
    STEARIC ACID  
    SODIUM BICARBONATE  
    SODIUM ALGINATE  
    TALC  
    TITANIUM DIOXIDE  
    TRIACETIN  
    TRIETHYL CITRATE  
    DIMETHICONE  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code 44;227
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57896-921-01 100 in 1 BOTTLE
    2 NDC:57896-921-10 1000 in 1 BOTTLE
    3 NDC:57896-921-25 250 in 1 BOTTLE
    4 NDC:57896-921-50 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 07/01/2000
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    Name Address ID/FEI Business Operations
    Geri-Care Pharmaceutical Corp 611196254 repack(57896-921)
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