ASPIRIN 81MG- aspirin enteric coated tablets 81mg tablet, delayed release

Aspirin 81mg by

Drug Labeling and Warnings

Aspirin 81mg by is a Otc medication manufactured, distributed, or labeled by VITANE PHARMACEUTICALS, INC, InvaHealth Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

PURPOSE

Pain reliever

USES

• Temporarily relieves minor aches and pains
• For use as directed by a doctor for the prevention of recurrent heart attack or stroke

Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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

Allergy Alert:

• Aspirin may cause a severe allergic reaction which may include:
• hives
• facial swelling
• asthma (wheezing)
• shock

SPL UNCLASSIFIED SECTION

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 non-prescription NSAIDs(aspirin, ibuprofen, naproxen, 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 SECTION

Do not use if:

You are allergic to aspirin or any other pain reliever/fever reducer.

ASK A DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug for

• gout
• diabetes
• arthritis

STOP USE SECTION

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
• redness or swelling is present
• new symptoms occur
• ringing in the ears or loss of hearing occurs.

PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional.

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 SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

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: consult a doctor

STORAGE

• Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F–86°F)
• Use by expiration date on package.

INACTIVE INGREDIENTS

Microcrystalline Cellulose, Talc, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Titanium Dioxide, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer, D&C Yellow #10, FD&C Yellow #6

ASK A DOCTOR BEFORE USE

• Stomach bleeding warning applies to you
• You have a history of stomach problems, such as heartburn
• You have a high blood pressure, heart disease, liver cirrhosis, or kidney disease
• You are taking a diuretic
• You have asthma

PRINCIPAL DISPLAY PANEL

NDC: 60577-808-01

Vitane's

Aspirin 81mg

Pain Reliever

Aspirin 81 mg (NSAID) Enteric Coated

60 tablets

INGREDIENTS AND APPEARANCE

ASPIRIN 81MG 
aspirin enteric coated tablets 81mg tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60577-808
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code	I1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60577-808-01	1 in 1 CARTON	10/15/2025
1		60 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 Drug	M013	10/15/2025

Labeler - VITANE PHARMACEUTICALS, INC (029029638)

Establishment
Name	Address	ID/FEI	Business Operations
InvaHealth Inc		116840615	manufacture(60577-808)