Label: CAREALL ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 51824-077-01
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2023

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

  • Active Ingredient

    Aspirin 81mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain Reliever

  • 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 (1-800-222-1222) right away.

  • Uses

    For the temporary relief of minor aches and pain or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

  • 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 included

    • hives 
    • facial swelling
    • asthma (wheezing) 
    • shock

    Stomach Bleeding Warning: this product containers 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 have asthma
    • You have taken a diuretic

    Ask a doctor or pharmacist before use if you are taking a prescription drug for:

    • diabetes
    • gout
    • arthritis

    Stop use and ask a doctor if:

    • An allergic reaction occurs. Seek medical help right away
    • 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
    • Redness or swelling is present
    • Ringing in the ears or loss of hearing occurs
    • Pain gets worse or lasts more than 10 days

    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 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 years of age: consult a doctor

  • Inactive Ingredients

    colloidal silicon dioxide, corn starch, crospovidone, D C yellow 10 aluminum lake, FD C yellow 6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl ceitrate

  • PRINCIPAL DISPLAY PANEL

    ASP81120 Label

  • INGREDIENTS AND APPEARANCE
    CAREALL ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-077
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 81 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triethyl Citrate (UNII: 8Z96QXD6UM)  
    talc (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Coloryellow (yellow) Scoreno score
    ShapeROUND (round convex) Size7mm
    FlavorImprint Code A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-077-01120 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/01/2020
    Labeler - New World Imports, Inc (075372276)