Label: HANDY SOLUTIONS GENUINE ASPIRIN BAYER- aspirin tablet

  • NDC Code(s): 67751-009-01, 67751-009-02
  • Packager: Navajo Manufacturing Company 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 August 21, 2013

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

  • Handy Solutions GENUINE ASPIRIN BAYER

    Drug Facts

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  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)1


    1
    nonsteroidal anti-inflammatory drug
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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    temporarily relieves

    • headache
    • menstrual pain
    • minor pain of arthritis
    • muscle pain
    • pain and fever of colds
    • toothache
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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
    • you have a sodium-restricted diet

    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

    • 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
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • fever lasts more than 3 days
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs

    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

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
    • children under 12 years: consult a doctor
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  • Other information

    • each tablet contains: sodium 47 mg
    • store at room temperature. Avoid excessive heat and moisture. Keep desiccant and product in original bottle. Immediately close cap tightly after use.
    • save carton for full directions and warnings
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  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, hypromellose, sodium carbonate, zinc stearate

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  • Questions or comments?

    1-800-331-4536 (Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

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  • Handy Solutions GENUINE ASPIRIN BAYER 4 Tablets (67751-009-01) | Handy Solutions GENUINE ASPIRIN BAYER 2 Tablets (67751-009-02)
  • INGREDIENTS AND APPEARANCE
    HANDY SOLUTIONS GENUINE ASPIRIN BAYER 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-009
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    Carnauba Wax (UNII: R12CBM0EIZ) 5.00 mg
    Silicon Dioxide (UNII: ETJ7Z6XBU4) 8.50 mg
    Hypromelloses (UNII: 3NXW29V3WO) 16.00 mg
    Sodium carbonate (UNII: 45P3261C7T) 25.00 mg
    Zinc stearate (UNII: H92E6QA4FV) 4.61 mg
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code BA;325
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67751-009-01 1 in 1 BLISTER PACK
    1 4 in 1 POUCH
    2 NDC:67751-009-02 1 in 1 BLISTER PACK
    2 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 08/21/2013
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    Name Address ID/FEI Business Operations
    Bayer HealthCare LLC 127769128 manufacture(67751-009)
    Establishment
    Name Address ID/FEI Business Operations
    Navajo Manufacturing Company Inc. 091917799 repack(67751-009) , relabel(67751-009)
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