Label: ASPIRIN ENTERIC SAFETY COATED- aspirin tablet, delayed release 

  • NDC Code(s): 41520-440-12, 41520-440-14, 41520-440-30
  • Packager: Care One (American Sales Company)
  • 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 12/12

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti- inflammatory drug

    Close
  • Purpose

    Pain reliever

    Close
  • Uses

    •  temporarily relieves minor aches and pains
    • other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief.
    Close
  • 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 have ever had an allergic reaction to any other pain reliever/fever reducer

    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 a doctor or pharmacist before use if you are

    taking a prescription drug for:

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

    Stop use and ask a doctor if

    • 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
      • allergic reaction occurs
      • ringing in the ears or a loss of hearing occurs
      • pain gets worse or lasts more than 10 days
      • fever gets worse or lasts more than 3 days
      • any new symptoms appear
      • redness or swelling is present in the painful area

    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

    In case of overdose, get medical help or contact a Poison Control Center right away. 

    Close
  • Directions

    • do not exceed recommended dosage
    • drink a full glass of water with each dose
    • adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours, unless directed by a doctor
    • children under 12 years of age: consult a doctor
    Close
  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • do not use if imprinted safety seal under cap is broken or missing
    • †This product is not manufactured or distributed by Bayer Corporation Consumer Care Division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg
    Close
  • Inactive ingredients

    *acetylated monoglycerides, *anhydrous lactose, *carnauba wax, colloidal silicon dioxide,*corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron
    oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, povidone, pregelatinized starch, *propylene glycol, *simethicone, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacitin, and triethyl citrate. *May also contain.

    Close
  • Principal Display Panel

    Compare to the active ingredient in Aspirin Regimen Bayer® 81 mg 

    SEE NEW WARNINGS INFORMATION

    Enteric safety Coated/ Aspirin regimen**

    **Ask your doctor before taking this product on a regular basis

    Aspirin 81 mg

    adult low strength

    Pain reliever (NSAID)*

    Low Dose

    Distributed by: American sales company

    4201 Walden avenue, Lancaster, NY 14086

    www.care1.info

    Close
  • Product Label

    CareOne

    Aspirin 81 mg

     

    Close
  • INGREDIENTS AND APPEARANCE
    ASPIRIN  ENTERIC SAFETY COATED
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-440
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    DIACETYLATED MONOGLYCERIDES  
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    HYPROMELLOSES  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
    FERRIC OXIDE YELLOW  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POLYETHYLENE GLYCOL 400  
    POLYSORBATE 80  
    POVIDONES  
    STARCH, CORN  
    PROPYLENE GLYCOL  
    DIMETHICONE  
    SILICON DIOXIDE  
    SODIUM BICARBONATE  
    SODIUM HYDROXIDE  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    TRIACETIN  
    TRIETHYL CITRATE  
    FD&C YELLOW NO. 6  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code E;HEART;81
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-440-14 1 in 1 BOX
    1 144 in 1 BOTTLE
    2 NDC:41520-440-30 1 in 1 BOX
    2 300 in 1 BOTTLE
    3 NDC:41520-440-12 1 in 1 BOX
    3 120 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 07/15/2010
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P and L Development of New York Corporation (800014821)
    Close