Label: REGULAR STRENGTH ASPIRIN EC- aspirin tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 20, 2011

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)                  Purpose

    Aspirin 325 mg (NSAID*).............................Pain reliever

    *nonsteroidal anti-inflammatory drug

    Purpose
    Pain reliever
  • INDICATIONS & USAGE

    Uses
    • for the temporary relief of minor aches and pains due to
      • headache
      • colds
      • muscle pain
      • menstrual pain
      • toothache
      • minor pain of arthritis
    • or as directed by your doctor
  • WARNINGS

    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 or 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 inclue:
    • 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
  • DO NOT USE

    Do not use
    • if you are allergic to aspirin or any other pain reliever/fever reducer
  • ASK DOCTOR

    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 are taking a diuretic
    • you have asthma
    • you have not been drinking fluids
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drugs
    • under a doctor's care for any serious condition
  • STOP USE

    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
    • 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 OR BREAST FEEDING

    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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    Other information
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredients corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
  • QUESTIONS

    Questions? To Report Adverse Drug Event Call: (800) 616-2471

    Repacked by:
    H.J. Harkins Company, Inc.
    Nipomo, CA 93444
  • PRINCIPAL DISPLAY PANEL

    IMAGE OF BOTTLE LABEL
  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH ASPIRIN EC  
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-018(NDC:0904-2013)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColororangeScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-018-1414 in 1 BOTTLE
    2NDC:52959-018-2020 in 1 BOTTLE
    3NDC:52959-018-2424 in 1 BOTTLE
    4NDC:52959-018-3030 in 1 BOTTLE
    5NDC:52959-018-4040 in 1 BOTTLE
    6NDC:52959-018-6060 in 1 BOTTLE
    7NDC:52959-018-8080 in 1 BOTTLE
    8NDC:52959-018-00100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34309/09/2011
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - Major Pharmaceuticals Inc (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Labs Inc037052099manufacture
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