ASPIRIN ENTERIC COATED- aspirin 81 mg tablet 
Lodaat LLC

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372 - Aspirin 81mg

Active ingredient(s)

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

Purpose

Pain reliever

Use(s)

for the temporary relief of minor aches and pain or as recommended by your doctor. 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: Aspirin may cause a severe allergic reaction which may include:

Stomach bleeding warning: This product contains an NSAID which may cause severe

stomach bleeding. The chance is higher if you:

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

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

  • taking a prescription drug for anticoagulation (thinning the blood)
  • diabetes
  • gout
  • 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 than10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • You may report side effects to 1-888-952-0050

Pregnancy/Breastfeeding

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
specifically 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 accidental 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

Inactive ingredients

ccolloidal silicon dioxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake,
hypromellose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate.

Principal Display Panel

Aspirin 81mg EC

Aspirin 81mg EC

ASPIRIN  ENTERIC COATED
aspirin 81 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83139-372
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83139-372-6060 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/31/2023
Labeler - Lodaat LLC (011845714)

Revised: 1/2023
Document Id: c8032d71-2485-4ab4-a20f-153fc3dc6281
Set id: 04017bc9-602a-4204-96a9-b7f9713155f6
Version: 4
Effective Time: 20230131
 
Lodaat LLC