Label: CAREALL ASPIRIN- aspirin tablet, chewable

  • NDC Code(s): 51824-057-36
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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

  • Active Ingredient

    Aspirin 81 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever 

  • Keep out of reach of children.

    In case of accidental overdose, get medical help or contact aPoison Control Center (1-800-222-1222) right away

  • Uses

    for the temporary relief of minor aches and paines or as recommended by your doctor

  • 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 NSAID, which may cause severe stomach bleeding.  The chance is higher if you:

    -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)

    -Take more or for a longer time than directed

    -Are age 60 or older

    -Have 3 or more alcoholic drinks every day while using this product

    Do not use:

    -if you are allergic to aspirin or other pain relievers / fever reducers

    -For at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

    -If you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if:

    -Stomach bleeding warning applies to user

    -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 of pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis.

    Stop use and ask a doctor if:

    -You experience any of the following signs of stomach bleeding: feel faint, vomit blood, has bloody or black stool, has stomach pain that does not get better

    -An allergic reaction occurs.  Seek medical help help right away

    -New symptoms occur

    -Redness or swelling is present

    -Pain gets worse or lasts for more than 10 days

    -Ringing in the ears or loss of hearing occurs

    -You may report side effects to 1-888-952-0050

    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 unborn child or complications during delivery.

  • 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: consult a doctor

  • Inactive Ingredients

    corn starch, dextrates, FD C yellow 6 aluminum lake, orange flavor, saccharin sodium

  • PRINCIPAL DISPLAY PANEL

    CCA36 Label
  • INGREDIENTS AND APPEARANCE
    CAREALL ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin81 mg
    Inactive Ingredients
    Ingredient NameStrength
    Dextrates (UNII: G263MI44RU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Starch, Corn (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Colororange (Pale Orange) Scoreno score
    ShapeROUND (Round) Size8mm
    FlavorImprint Code AZ;013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-057-3636 in 1 BOTTLE; Type 0: Not a Combination Product03/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/29/2016
    Labeler - New World Imports, Inc (075372276)