Label: ENTERIC COATED ASPIRIN - aspirin tablet, delayed release

  • NDC Code(s): 0536-3313-01, 0536-3313-10
  • Packager: Rugby Laboratories, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/11

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

  • ACTIVE INGREDIENT

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

    Purpose
    Pain reliever
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  • INDICATIONS & USAGE

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

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  • DO NOT USE

    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer
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  • 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
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  • 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
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  • 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
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  • 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.
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  • 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.
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  • 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
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  • STORAGE AND HANDLING

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

    Questions or comments?
    call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday
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  • INGREDIENTS AND APPEARANCE
    ENTERIC COATED ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-3313
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    HYPROMELLOSE 2910 (6 MPA.S)  
    HYPROMELLOSE 2910 (15 MPA.S)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POLYSORBATE 80  
    SILICON DIOXIDE  
    DIMETHICONE  
    SODIUM HYDROXIDE  
    SODIUM LAURYL SULFATE  
    TALC  
    TITANIUM DIOXIDE  
    TRIETHYL CITRATE  
    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
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