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 Velocity Pharma. 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 81 mg (NSAID)


Purpose



Pain Relief


Uses



  • temporarily relieves minor aches and pains

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
  • Asthma (wheezing)
  • Shock
  • Facial Swelling

    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 other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
  • have 3 or more alcoholic drinks every day while using this product
  • takes more or for a longer time than directed

    Do not use

  • if you have ever had an allergic reaction to any pain reliever or fever reducer.

    Ask a doctor before use if:

  • The stomach bleeding warning applies to you
  • You have history of stomach problems such as heartburn
  • You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • You have asthma
  • You are taking a diuretic

    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 experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • New symptoms occur
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs

    These could be signs of serious conditions.

    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.


Directions



Adults and Children 12 years and over:

For temporary relief of minor aches and pains, take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours unless directed by a doctor.

Children under 12 years of age: Do not use unless directed by a doctor.


Other Information



  • Store at a controlled temperature between 62 and 77 degrees F

Inactive Ingredients



Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.


Questions?



Call 1-855-314-1850

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Velocity Pharma LLC


Package Label.Principal Display Panel



NDC: 76168-009-10 –60 COUNT

Enteric Coated to help prevent upset stomach


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