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

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ACTIVE INGREDIENT

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

PURPOSE

Pain reliever

USES

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:

Stomach Bleeding Warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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

STOP USE SECTION

Stop use and ask a doctor if:

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:

STORAGE

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

PRINCIPAL DISPLAY PANEL

NDC 60577-808-01

Vitane's

Aspirin 81mg

Pain Reliever

Aspirin 81 mg (NSAID) Enteric Coated

60 tablets

Aspirin 81mg LabelASPIRIN 81 mg IFC

ASPIRIN 81MG 
aspirin enteric coated tablets 81mg tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60577-808
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
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
ColoryellowScoreno score
ShapeROUNDSize4mm
FlavorImprint Code I1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60577-808-011 in 1 CARTON10/15/2025
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01310/15/2025
Labeler - VITANE PHARMACEUTICALS, INC (029029638)
Establishment
NameAddressID/FEIBusiness Operations
InvaHealth Inc116840615manufacture(60577-808)

Revised: 10/2025
Document Id: 41386de5-5858-efab-e063-6294a90afd9c
Set id: 41386de5-5857-efab-e063-6294a90afd9c
Version: 1
Effective Time: 20251015
 
VITANE PHARMACEUTICALS, INC