St. Joseph Low Dose Aspirin

St. Joseph Low Dose Aspirin
SPL v7
SPL
SPL Set ID dbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f
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
Fd&c Red No. 40 Fd&c Yellow No. 6 Methacrylic Acid Microcrystalline Cellulose Starch, Corn Silicon Dioxide Sodium Bicarbonate Sodium Lauryl Sulfate Stearic Acid Talc Triethyl Citrate Polyethylene Glycol, Unspecified Triacetin Polydextrose Shellac Titanium Dioxide Hypromellose, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: SJ Shape: round Color: white Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-17 Until 2018-05-01

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pain
  • ask your doctor about other uses for St. Joseph Safety Coated 81 mg Aspirin
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 50568-5

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

Section 50570-1

Do not useif you are allergic to aspirin or any other pain reliever/fever reducer

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.

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
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.

Other Information
  • store at 20-25°C (68-77°F)
  • close cap tightly after use
Inactive Ingredients

colloidal anhydrous silica, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid- ethyl acrylate copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

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
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.
Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID)

nonsteroidal anti-inflammatory drug

Principal Display Panel 36 Tablet Bottle Box

•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


Structured Label Content

Uses
  • temporarily relieves minor aches and pain
  • ask your doctor about other uses for St. Joseph Safety Coated 81 mg Aspirin
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 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Do not useif you are allergic to aspirin or any other pain reliever/fever reducer

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.

Purpose

Pain reliever

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
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.

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • close cap tightly after use
Inactive Ingredients (Inactive ingredients)

colloidal anhydrous silica, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid- ethyl acrylate copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

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
Stop Use and Ask A Doctor If (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.
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID)

nonsteroidal anti-inflammatory drug

Principal Display Panel 36 Tablet Bottle Box (PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box)

•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


Advanced Ingredient Data


Raw Label Data

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