st. joseph ®

st. joseph ®
SPL v4
SPL
SPL Set ID 248cd302-e380-4837-bdae-9df620b67e8a
Route
oral
Published
Effective Date 2022-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (81 mg)
Inactive Ingredients
starch, corn dextrates fd&c yellow no. 6 maltodextrin sucralose

Identifiers & Packaging

Pill Appearance
Imprint: SJC Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
otc monograph drug active Since 2017-02-17

Purpose

Pain reliever

Description

Drug Facts


Medication Information

Active Ingredient

Aspirin 81 mg (NSAID)

nonsteroidal anti-inflammatory drug

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

Pain reliever

Directions
  • drink a full glass of water with each dose
  • adults and children 12 years 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: 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

corn starch, dextrates hydrated, FD&C yellow #6 aluminum lake, flavor, maltodextrin, sucralose

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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 for 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.
Section 50568-5

Ask a doctor or pharmacist before use if you aretaking a prescription drug for gout, diabetes or arthritis

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Do Not Use
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
Allergy Alert

Aspirin may cause a severe allergic reaction which may include:

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

Questions Or Comments?

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

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
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
Principal Display Panel 36 Tablet Bottle Box

• ADULT ASPIRIN REGIMEN

ST. JOSEPH ®

LOW DOSE ASPIRIN

CHEWABLE PAIN RELIEVER (NSAID)

81 mg

AMERICA'S

ASPIRIN

100

YEARS

CHEWABLE

Orange

Flavored

36

Chewable

Tablets


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID)

nonsteroidal anti-inflammatory drug

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

Pain reliever

Directions
  • drink a full glass of water with each dose
  • adults and children 12 years 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: do not use unless directed by a doctor
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • close cap tightly after use
Inactive Ingredients (Inactive ingredients)

corn starch, dextrates hydrated, FD&C yellow #6 aluminum lake, flavor, maltodextrin, sucralose

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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 for 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.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking a prescription drug for gout, diabetes or arthritis

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Do Not Use (Do not use)
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
Allergy Alert (Allergy alert)

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Reye's Syndrome (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.

Questions Or Comments? (Questions or comments?)

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

Stomach Bleeding Warning (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
Ask A Doctor Before Use If (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
Principal Display Panel 36 Tablet Bottle Box (PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box)

• ADULT ASPIRIN REGIMEN

ST. JOSEPH ®

LOW DOSE ASPIRIN

CHEWABLE PAIN RELIEVER (NSAID)

81 mg

AMERICA'S

ASPIRIN

100

YEARS

CHEWABLE

Orange

Flavored

36

Chewable

Tablets


Advanced Ingredient Data


Raw Label Data

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