Label: CAREALL ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 51824-055-01
  • 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 October 10, 2018

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

  • Active Ingredient

    Aspirin 81mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain Reliever

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  • 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 immediately.

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  • Uses

    For the temporary relief of minor aches and pains 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.

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  • Warnings

    Rene'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 with may included hives, facial swelling, asthma (wheezing) and 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 2 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 relievers / fever reducers

    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 anticoagulation (thinning of the blood), 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
    New symptoms occur
    Redness or swelling is present
    Ringing in the ears or loss of hearing occurs
    Pain gets worse or lasts more than 10 days
    You may report serious 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 the 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 years: consult a doctor

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  • Inactive Ingredients

    andhydrous lactose, carnauba was, croscarmellose sodium, D C yellow 10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, silicon dioxide, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

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  • INGREDIENTS AND APPEARANCE
    CAREALL ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-055
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Iron (UNII: E1UOL152H7)  
    Methacrylic Acid (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triethyl Citrate (UNII: 8Z96QXD6UM)  
    talc (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color yellow (yellow) Score no score
    Shape ROUND (round) Size 8mm
    Flavor Imprint Code A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51824-055-01 120 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 03/01/2016
    Labeler - New World Imports, Inc (075372276)
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