FDA Label for Aspirin

View Indications, Usage & Precautions

Aspirin Product Label

The following document was submitted to the FDA by the labeler of this product Time Cap Labs Inc. 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 Ingredients




Each tablet contains Aspirin 325 mg (NSAID)


Inactive Ingredients



Corn Starch, Croscramellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide


Purpose



Pain Reliever


Dosage And Administration



Drink a full glass of water with each doses

Adults and children 12 years and over: TAKE 1 TO 2 TABLETS EVERY 4 HOURS WHILE SYMPTOMS  LAST.  DO NOT TAKE MORE THAN 12 TABLETS IN 24 HOURS, UNLESS DIRECTED BY A DOCTOR.

Children under 12 years: CONSULT A DOCTOR.


Indications And Usage



For the temporary relief of aches and pains due to:

headache, colds,menstral pain, muscle pain, toothache,minor pain of arthritis or as directed by your doctor


Warnings



Reyes'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 reactin, which may include hives, facial swelling, shock, asthma (wheezing)

Stomach bleeding warning:  This produc tcontains 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 non prescription 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.


Keep Out Of The Reach Of Children



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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