St. Joseph Low Dose Aspirin Tablet, Film Coated
FDA Label NDC 69536-181

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Foundation Consumer Healthcare for the product St. Joseph Low Dose Aspirin (NDC 69536-181). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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)

Principal Display Panel (36 Tablet Bottle Box)

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