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safety coated aspirin (Care One (American Sales Company))

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE in 1 BOX (41520-103-18) > 180 TABLET in 1 BOTTLE Label Information

Complete safety coated aspirin Information

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug 


  • Purpose

    Pain reliever 


  • Uses

    • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

  • 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:  

    • facial swelling
    • hives
    • 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 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:

    • gout
    • diabetes
    • arthritis 

    Stop use and ask a doctor if
    • you experienece 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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during the 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 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
    • children under 12 years: do not use unless directed by a doctor 

  • Other information

    • store at controlled room temperature 15º-30ºC (59º-86ºF)
    • do not use if imprinted safety seal under cap is broken or missing
    • † This product is not manufactured or distributed by McNeil Consumer & Speciality Pharmaceuticals, owner of the registered trademark ST. JOSEPH® 81 mg

  • Inactive ingredients

    anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium,FD&C Red # 40 Aluminum lake,FD&C Yellow # 6 Aluminum Lake,  iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80,  simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate


  • Principal Display Panel

    Compare to the active ingredient in St.Joseph® Aspirin †

    Adult Low Strength

    Aspirin Regimen**

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

    SAFETY COATED ASPIRIN

    protects against stomach upset

    pain reliever (NSAID*)

    See New Warnings Information

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by: American Sales Company

    4201 walden avenue, Lancaster, NY 14086

    www.care1.com


  • Product Label

    CareOne

    Aspirin 81 mg Enteric Coated


  • INGREDIENTS AND APPEARANCE
    SAFETY COATED ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-103
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color ORANGE (peach) Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code heart;328
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-103-18 1 in 1 BOX
    1 180 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 07/30/2010
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P and L Development of New York Corporation (800014821)