Label: ADULTS LOW STRENGTH ASPIRIN- aspirin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 1, 2015

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

  • Drug Facts
  • Active ingredient (in each tablet)

    Aspirin 81mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Uses

    • temporarily relieves minor aches and pains
    • Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief

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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 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 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
    • pain lasts for more than 10 days
    • pain persists or gets worse
    • new symptoms occur
    • redness or swelling is present
    • ringing in the ear or loss of hearing occurs. These could be signs of a serious condition

    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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away

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  • Directions

    • do not exceed recommended dosage
    • drink a full glass of water with each dose
    • adults and children 12 years of age and older: take 4 to 8 tablets every 4 hours not to exceed 49 tablets in 24 hours, or as directed by a doctor
    • children under 12 years of age: consult a doctor
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  • Other information

    Store at controlled room temperature 15º - 30ºC (59º - 86ºF)

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  • Inactive ingredients

    hydrophilic pyrogenic silica, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, sodium starch glycolate, pregelatinized starch (Starch 1500), talc, titanium dioxide, triacetin, triethyl citrate

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  • Questions?

    For questions regarding this product, please contact 1-204-663-2866

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  • Package Labeling
  • INGREDIENTS AND APPEARANCE
    ADULTS LOW STRENGTH ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62049-001
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    triacetin (UNII: XHX3C3X673)  
    triethyl citrate (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color blue (blue) Score no score
    Shape ROUND (round) Size 8mm
    Flavor Imprint Code C;
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62049-001-00 100 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 not final part343 06/01/2015
    Labeler - Genvion Corporation (245221226)
    Establishment
    Name Address ID/FEI Business Operations
    Genvion Corporation 245221226 manufacture(62049-001)
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