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Regular Strength Aspirin EC (NCS HealthCare of KY, Inc dba Vangard Labs)

Available Formats

Dosage Form Package Information Links
TABLET, DELAYED RELEASE 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-0564-39) Label Information

Complete Regular Strength Aspirin EC Information

  • Active ingredient(s)

     Aspirin 325mg (NSAID*)

    *nonsteroidal anti-inflammatory drug


  • Purpose

     Pain reliever


  • Use(s)

     for the temporary relief of minor aches and pains due to headache, menstrual pain, colds, toothache, muscle pain, minor pain of arthritis or as directed by a doctor.


  • 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: 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.

    For external use only

    Do not use

     If you are allergic to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if

     stomache 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 are taking a diuretic, you have asthma, you have not been drinking fluids

    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

    When using this product

    Stop use and ask a doctor if

     you expierence any of the following signs of stomach bleeding:

    feel faint, have bloody or black stools, vomit blood, have stomcah 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.

    Pregnancy/Breastfeeding

     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 (1-2800-222-1222).


  • Directions

     drink a full glass of water with each dose, adults and children 12 years and over take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor, children under 12 years: consult 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


  • Storage


  • Inactive ingredients

    corn starch, croscarmellose sodium, D & C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hyromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simehticone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate


  • Questions

     Adverse Drug Event Call: (800) 616-2471


  • Principal Display Panel

     Aspirin (NSAID*) EC Tabs 325mg (5gr)

    *nonsteroidal anti-inflammatory drug

    Aspirin (NSAID*) EC Tablets 325mg (5gr)


  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH ASPIRIN EC 
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-0564(NDC:0904-2013)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code T
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0615-0564-39 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 09/09/2011
    Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
    Establishment
    Name Address ID/FEI Business Operations
    NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL(0615-0564) , REPACK(0615-0564)