FDA Label for St. Joseph Low Dose Aspirin

Other

Drug Facts

Dist. by: Foundation Consumer Healthcare, LLC.
Pittsburgh, PA 15205

Active Ingredient (In Each Tablet)

Aspirin 81 mg (NSAID)

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• temporarily relieves minor aches and pain
• ask your doctor about other uses for St. Joseph Safety Coated 81 mg Aspirin

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 or 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
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • new symptoms occur. These could be signs of a serious condition.
  
  

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 of age and over: take 4 to 8 tablets every 4 hours not to 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 20-25°C (68-77°F)
• close cap tightly after use

Inactive Ingredients

FD&C red #40, FD&C yellow #6, methacrylic acid copolymer, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, triethyl citrate

Questions Or Comments?

Call 1-855-785-6381 weekdays 9 AM to 5 PM EST

Principal Display Panel - 36 Tablet Bottle Box

NDC 69536-181-36

ADULT ASPIRIN REGIMEN^†

ST. JOSEPH_®

LOW DOSE ASPIRIN
SAFETY COATED
PAIN RELIEVER (NSAID)

81mg

AMERICA'S
ASPIRIN

100
YEARS

DOCTOR RECOMMENDED

Enteric
Coated

36
Coated
Tablets

PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box - aspirin 01