Label: ENTERIC COATED ASPIRIN- regular strength tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 18, 2017

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  • ACTIVE INGREDIENTS (IN EACH TABLET)

    Aspirin 325mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever

  • USES

    for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

  • 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 other pain relievers/fever reducers

    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:

    • anticoagulation (thinning the blood)
    • diabetes
    • gout
    • arthritis

    Stop use and ask a doctor if

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

    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 specifically 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 over: take 1 or 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor
  • OTHER INFORMATION

    • store at room temperature
    • do not use if imprinted safety seal under cap is broken or missing

    You may report serious side effects to: 1-888-952-0050

  • INACTIVE INGREDIENTS

    corrn starch, croscarmellose sodium, Dimethicone, D&C Yellow # 10 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

  • Regular Strength

    Label Image
  • INGREDIENTS AND APPEARANCE
    ENTERIC COATED ASPIRIN  
    regular strength tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0003(NDC:0603-0169)
    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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0003-1 30 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    2NDC:50090-0003-3 100 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    3NDC:50090-0003-5 90 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34302/04/2011
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0003) , REPACK(50090-0003)
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