ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN- aspirin tablet, chewable

St. Joseph Chewable Low Dose Aspirin by

Drug Labeling and Warnings

St. Joseph Chewable Low Dose Aspirin by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)1

1 nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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

Warnings

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

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

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

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 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.

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.

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 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

Questions or comments?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box

NDC: 69536-281-36

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

INGREDIENTS AND APPEARANCE

ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69536-281
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	SJC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69536-281-36	1 in 1 BOX	02/17/2017
1		36 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69536-281-10	3 in 1 BOX	02/17/2017
2		108 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	02/17/2017

Labeler - Foundation Consumer Healthcare LLC (079675882)