Label: ENTERIC COATED ASPIRIN REGULAR STRENGTH- aspirin tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose
    Pain reliever

  • INDICATIONS & USAGE

    Uses
    temporarily relieves minor aches and pains due to:

    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • colds
    • minor arthritis pain

    or as recommended by a 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 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
  • 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

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis

  • STOP USE

    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
    have bloody or black stools
    vomit blood
    have stomach pain that does not get better

    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs

    These could be signs of a serious condition.

  • 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • 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

  • SPL UNCLASSIFIED SECTION

    Other information

    • each tablet contains: sodium 1 mg (VERY LOW SODIUM)
    • 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 and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

  • QUESTIONS

    Questions or comments? call 1-877-290-4008

  • HOW SUPPLIED

    NDC: 71335-0157-1: 30 Tablets in a BOTTLE

    NDC: 71335-0157-2: 60 Tablets in a BOTTLE

    NDC: 71335-0157-3: 100 Tablets in a BOTTLE

    NDC: 71335-0157-4: 90 Tablets in a BOTTLE

    NDC: 71335-0157-5: 20 Tablets in a BOTTLE

    NDC: 71335-0157-6: 45 Tablets in a BOTTLE

    NDC: 71335-0157-7: 120 Tablets in a BOTTLE

    NDC: 71335-0157-8: 7 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Aspirin E.C 325mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    ENTERIC COATED ASPIRIN  REGULAR STRENGTH
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0157(NDC:49483-331)
    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 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-0157-130 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    2NDC:71335-0157-260 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    3NDC:71335-0157-3100 in 1 BOTTLE; Type 0: Not a Combination Product04/19/2018
    4NDC:71335-0157-490 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    5NDC:71335-0157-520 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    6NDC:71335-0157-645 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    7NDC:71335-0157-7120 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    8NDC:71335-0157-87 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/04/2011
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0157) , RELABEL(71335-0157)