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Enteric Coated Aspirin (Rugby Laboratories, Inc)

Available Formats

Dosage Form Package Information Links
TABLET, DELAYED RELEASE 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0536-3313-10) Label Information
TABLET, DELAYED RELEASE 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0536-3313-01) Label Information

Complete Enteric Coated Aspirin Information

  • ACTIVE INGREDIENT

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

  • PURPOSE

    Purpose
    Pain reliever

  • INDICATIONS & USAGE

    Uses
    temporarily relieves
    • headache
    • muscle pain
    • menstrual pain
    • toothache
    • minor pain of arthritis
    • pain and fever of colds

  • 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
    • shock
    • facial swelling
    • asthma (wheezing)
    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user
    • has had stomach ulcers or bleeding problems
    • takes a blood thinning (anticoagulant) or steroid drug
    • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • takes more or for a longer time than directed
    • has 3 or more alcoholic drinks every day while using this product
    • is age 60 or older


  • DO NOT USE

    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

  • ASK DOCTOR

    Ask a doctor before use if
    • stomach bleeding warning applies to user
    • user has a history of stomach problems such as heartburn
    • user has high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • user is taking a diuretic
    • user has asthma
    • user has not been drinking fluids

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if user is
    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drug
    • under a doctor's care for any serious condition

  • STOP USE

    Stop use and ask a doctor if
    • user experiences any of the following signs of stomach bleeding:
      • feels faint
      • vomits blood
      • has bloody or black stools
      • has 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.

  • DOSAGE & ADMINISTRATION

    Directions
    DRINK A FULL GLASS OF WATER WITH EACH DOSE
    • adults and children 12 years and over: 1 - 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
    • children under 12 years: ask a doctor

  • STORAGE AND HANDLING

    Other information
    • store at 20° - 25°C (68° - 77°F)

  • 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 or comments?
    call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

  • INGREDIENTS AND APPEARANCE
    ENTERIC COATED ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3313
    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:0536-3313-01 100 in 1 BOTTLE
    2 NDC:0536-3313-10 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 09/20/2011
    Labeler - Rugby Laboratories, Inc (109178264)
    Registrant - Time Cap Labs, Inc (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    Time Cap Labs, Inc 037052099 manufacture