Aspirin 81 mg -Low Dose Safety Coated

Aspirin 81 mg by

Drug Labeling and Warnings

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

Drug Details [pdf]

ASPIRIN 81 MG LOW DOSE- aspirin tablet, coated 
VITANE PHARMACEUTICALS, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aspirin 81 mg -Low Dose Safety Coated

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

◾ temporarily relieves
◾ muscle pain
◾ menstrual pain
◾ minor pain of arthritis

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 ulcer 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

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
◾ 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 more than 10 days
   ◾ redness or swelling is present
   ◾ fever lasts more than 3 days
   ◾ new symptoms occur
   ◾ 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 (1-800-222-1222) 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: consult a doctor.

Other information:

◾ Store at 25ºC excursions permitted between 15º-30ºC
◾ Use by expiration date on package

Other Ingredients:

Microcrystalline Cellulose, Croscarmellose sodium, Methacrylic acid copolymer, Titanium dioxide, Talcum, Stearic acid, Colloidal silicon dioxide, Triethyl citrate, D&C Yellow #10, FD&C Yellow #6.

Questions or comments?

Call 1-845-267-6700

Monday through Friday, 8 am to 5 pm EST or

www.vitanepharma.com

NDC: 60577-005-01

Vitane's Aspirin 81 mg
Pain Reliever (NSAID)*

Low Dose Safety Coated | Aspirin Regimen**

60 Enteric Coated Tablets

**Talk to your doctor or other healthcare provider before using this product for your heart.

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

MADE IN USA

Manufactured By:

Vitane Pharmaceuticals, Inc.

125 Wells Avenue

Congers, NY 10920 USA

www.vitanepharma

image description

ASPIRIN 81 MG  LOW DOSE
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60577-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize6mm
FlavorImprint Code I1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60577-005-011 in 1 CARTON07/02/202109/16/2023
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/02/202109/16/2023
Labeler - VITANE PHARMACEUTICALS, INC (029029638)
Establishment
NameAddressID/FEIBusiness Operations
VITANE PHARMACEUTICALS, INC.029029638manufacture(60577-005) , pack(60577-005) , label(60577-005)

Revised: 9/2023