FDA Label for Good Sense Aspirin

View Indications, Usage & Precautions

Good Sense Aspirin Product Label

The following document was submitted to the FDA by the labeler of this product L. Perrigo 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.

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

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 have ever had an allergic reaction to 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



  • •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 gets worse or lasts more than 3 days
  • •new symptoms occur
  • •ringing in the ears or a 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 (1-800-222-1222).


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

Inactive Ingredients



corn starch, dibasic calcium phosphate dihydrate, hypromellose, talc, triacetin


Questions?



1-800-719-9260


Package/Label Principal Display Panel



For Adults

Aspirin

Pain Reliever/Fever Reducer (NSAID)

Safe Pain Relief Plus Lifesaving Benefits

Talk to your doctor or other healthcare provider before using this product for your heart.

Compare to active ingredient of Bayer® Aspirin

100% SATISFACTION GUARANTEED

100 Coated Tablets – 325 mg


* Please review the disclaimer below.