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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 29, 2016

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

  • Active Ingredient

    Aspirin 81 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever / fever reducer

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  • Keep out of reach of children.

    In case of accidental overdose, contact a doctor or Poison Control Center immediately.

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  • Uses

    Temporary relief of minor aches and pains or as recommended by your doctor.  To reduce fever.

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  • 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 the user:

    -Has had stomach ulcers or bleeding problems

    -Takes a blood thinning (anticoagulant) or steroid drug

    -Takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

    -Takes more or for a longer time than directed

    -Is age 60 or older

    -Has 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.

    Ask a doctor before use if:

    -Stomach bleeding warning applies to user

    -user has history of stomach problems, such as heartburn

    -User has high blood pressure, heart disease, liver cirrhosis, or kidney disease

    -User is 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:

    -User experiences any of the following signs of stomach bleeding: feels faint, vomits blood, has bloody or black stools, 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.

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  • 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

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  • Inactive Ingredients

    corn starch, dextrates, FD C yellow 6, flavor, saccharin sodium

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  • INGREDIENTS AND APPEARANCE
    CAREALL ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-057
    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
    Dextrates (UNII: G263MI44RU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Starch, Corn (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color orange (Pale Orange) Score no score
    Shape ROUND (Round) Size 8mm
    Flavor Imprint Code AZ;013
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51824-057-36 36 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 03/29/2016
    Labeler - New World Imports, Inc (075372276)
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