FDA Label for Aspirin 50 Ct

View Indications, Usage & Precautions

Aspirin 50 Ct Product Label

The following document was submitted to the FDA by the labeler of this product Jhk Inc Dba American Safety & First Aid. 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

Stop use and ask a doctor if 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
  • ringing in the ears or loss of hearing occurs
  • pain or fever persists or gets worse
  • new symptoms occur
  • redness or swelling is present

Active Ingredient (In Each Tablets)



Aspirin 325 mg


Purpose



pain reliever/fever reducer


Use



temporarily relieves fever and minor aches and pains associated with:

  • headache
  • colds
  • muscular aches
  • toothache
  • minor arthritis pain
  • menstrual cramps

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 Warning



Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach Bleeding Warning



This product contains a nonsteroidal anti-inflammatory drug (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 prescription or nonprescription drugs containing an NSAID (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
  • with any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor

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 a history of stomach problems, such as heartburn

Otc - Stop Use



Stop use and ask a doctor if 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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Otc - When Using



When using this product do not exceed recommended dose.


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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



Adults and children 12 years of age and older: Take 2 tablets with water every 4 hours as needed, not to exceed 12 tablets in 24 hours, or as directed by doctor Children under 12 years of age: Ask a doctor.


Other Information



  • do not use if packet is opened or torn
  • Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Inactive Ingredients



microcrytalline cellulose, povidone, pregelatinized starch


Questions?



1-866-651-3660 Monday-Friday 8:00am-5:00pm EST


Principal Display Panel - 50 Tablet Packet Box



Product #1112

Aspirin

Pain Reliever/Fever Reducer (NSAID)

  • Temporary relief from pain and fever
  • Soothes muscle aches and minor
    arthritis pain
  • These quality comfort tablets are formulated and packaged for use in
    the workplace and meet ANSI Z308.1-2015 standards. They are
    sealed in tamper-evident packets for safety and convenience.

    50 Tablets • 2 Tablets Per Packet

    Manufactured for American Safety & First Aid
    Osceola, IN 46561


* Please review the disclaimer below.