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  5. Label Information: Bayer Genuine Aspirin

FDA Label for Bayer Genuine Aspirin

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSES
    4. USES
    5. REYE'S SYNDROME
    6. ALLERGY ALERT
    7. STOMACH BLEEDING WARNING
    8. OTC - DO NOT USE
    9. ASK A DOCTOR BEFORE USE IF
    10. OTC - ASK DOCTOR/PHARMACIST
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS OR COMMENTS?
    18. PRINCIPAL DISPLAY PANEL - 50 POUCH BOX

Bayer Genuine Aspirin Product Label

The following document was submitted to the FDA by the labeler of this product Your Safety Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredient (In Each Tablet)



Aspirin 325 mg (NSAID)

nonsteroidal anti-inflammatory drug


Purposes



Pain reliever/fever reducer


Uses



temporarily relieves

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • pain and fever of colds
  • minor pain of arthritis

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

Otc - Do Not Use



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

Otc - Ask Doctor/Pharmacist



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

Otc - Pregnancy Or Breast Feeding



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.


Otc - 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 right away.


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

Other Information



  • save carton for full directions and warnings
  • store at room temperature

Inactive Ingredients



carnauba wax

may contain this ingredient

, corn starch, hypromellose, powdered cellulose, triacetin


Questions Or Comments?



1-800-331-4536

(Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com


Principal Display Panel - 50 Pouch Box



GENUINE ASPIRIN
BAYER®
ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

THE WONDER DRUG®

325mg

Safe Pain Relief Plus
Lifesaving Benefits

COATED TABLETS

Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen.

PRINCIPAL DISPLAY PANEL - 50 Pouch Box - bayer 01

PRINCIPAL DISPLAY PANEL - 50 Pouch Box - bayer 01


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