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Pill Identifier Information of ASA 81 MG Delayed Release Tablet

Drug Information

ASA 81 MG Delayed Release Tablet

Imprint: AP;121
Shape: C48348
Color: C48330
Ingredients: Aspirin
Size: 8.00
Score: 1
Rxtty: SY
Author: Advance Pharmaceutical Inc.
Inactive Ingredients: CROSCARMELLOSE SODIUM / D&C YELLOW NO. 10 / HYPROMELLOSES / METHACRYLIC ACID / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOL 1000 / PROPYLENE GLYCOL / POVIDONE / SILICON DIOXIDE / SODIUM LAURYL SULFATE / STARCH, CORN / STEARIC ACID / TALC / TITANIUM DIOXIDE>

Complete Information

  • Active Ingredient

    (in each tablet)

    Aspirin 81 mg (NSAID) *

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain Reliever

  • Uses

    • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
  • 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 signs of  Reye’s syndrome, a rare but serious illness.

    Allergy Alert: Aspirin may cause a severe allergic reaction which may include

    • hives
    • asthma (wheezing)
    • shock
    • facial swelling

      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
    • takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
    • takes more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product.

      Do not use

    • if you have ever had an allergic reaction to any other pain reliever / 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, lever cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma

      Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout or arthritis
    • taking any other drug
    • under a doctor’s care for any serious condition

      Stop use and ask a doctor if

    • you experiences 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
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • ringing in the ears or a 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.

  • Directions

    DRINK A FULL GLASS OF WATER WITH EACH DOSE

    • adults and children 12 years and older : take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours.
    • Children under 12 years: ask a doctor
  • Other Information

    • store at 15-30 °C (59-86 °F)
  • Inactive Ingredients

    croscarmellose sodium, D&C Yellow #10 (Al-Lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

  • Questions or Comments

    Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

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

    Safer for your stomach than pain or Buffered Aspirin

    Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    184d7697-figure-01
    184d7697-figure-02
    184d7697-figure-03
    184d7697-figure-04

    NDC: 17714-121-12 – 120 Tablets

    NDC: 17714-121-06  - 240 Tablets

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-121
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code AP;121
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-121-12120 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2013
    2NDC:17714-121-06240 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2013
    3NDC:17714-121-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34306/12/1999
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-121)