ASPIRIN- aspirin tablet
Bedrock Brands, LLC (ST. JOSEPH)

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Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

Temporarily relieves minor aches and pains.

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
shock
asthma (wheezing)

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
have 3 or more alcoholic drinks every day while using this product
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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.

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 have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- ringing in the ears or a loss of hearing occurs

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. (1-800-222-1222)

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 while symptoms persist
do not 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 controlled room temperature 20º-25ºC (68º-77ºF)

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 toll free: 1 855 STJOE81

Principal Display Panel

• ADULT ASPIRIN REGIMEN‡

LOW DOSE ASPIRIN

SAFETY COATED†

PAIN RELIEVER (NSAID)

81 mg

DOCTOR RECOMMENDED

Enteric Coated

Micro** Tablets

Dist. by: St. Josephs Health Products, LLC

Irvington, NY 10533

Find out more at stjosephaspirin.com

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Gluten Free

†Coating Helps Protect Against Stomach Upset

‡Talk to your doctor before starting an aspirin regimen. Aspirin is not right for everyone.

**Now in a new, smaller, easier to swallow "micro tablet"

Product Label

St. Joseph Low Dose Aspirin Tablets

ASPIRIN
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76000-231
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	white (PEACH)	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	SJ
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76000-231-36	1 in 1 BOX	05/30/2014	12/31/2018
1		36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:76000-231-12	1 in 1 BOX	05/30/2014	12/31/2018
2		120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:76000-231-20	1 in 1 BOX	05/30/2014	12/31/2018
3		200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:76000-231-30	1 in 1 BOX	05/30/2014	12/31/2018
4		300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC:76000-231-15	1 in 1 BOX	05/30/2014	12/31/2018
5		150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC:76000-231-65	1 in 1 BOX	05/30/2014	12/31/2018
6		365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	05/30/2014	12/31/2018

Labeler - Bedrock Brands, LLC (ST. JOSEPH) (829056162)

Revised: 1/2025

Document Id: 9ec79c37-7a13-40a7-ab8e-36eac9adfc32

Set id: dcd96650-4dbe-43cf-abf4-ac08d160f1fc

Version: 4

Effective Time: 20250108

Bedrock Brands, LLC (ST. JOSEPH)