Label: SAFETY COATED ASPIRIN- aspirin tablet 

  • Label RSS
  • NDC Code(s): 41520-103-18
  • Packager: Care One (American Sales Company)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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
    • 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
    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:  

    • 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. 

    Close
  • 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 
    Close
  • 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
    Close
  • 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

    Close
  • 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

    Close
  • Product Label

    CareOne

    Aspirin 81 mg Enteric Coated

    Close
  • INGREDIENTS AND APPEARANCE
    SAFETY COATED ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-103
    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
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    FERRIC OXIDE RED  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
    CELLULOSE, MICROCRYSTALLINE  
    POLYSORBATE 80  
    DIMETHICONE  
    SODIUM HYDROXIDE  
    SODIUM LAURYL SULFATE  
    TALC  
    TRIETHYL CITRATE  
    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)
    Close