ASPIRIN 81MG ENTERIC COATED DELAYED RELEASE- aspirin tablet, coated 
Allegiant Health

----------

405 - Aspirin 81mg

Active ingredient(s)

Aspirin 81mg (NSAID)*

Purpose

Pain reliever

Use(s)

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 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

you are taking a prescription drug for

  • anticoagulation (thinning of 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 than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • You may report serious 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

Other information

Inactive ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow

#10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80,

simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

Questions

1-888-952-0050, Monday Through Friday 9am-5pm

Principal Display Panel

Aspirin 81mg

Aspirin 81mg


ASPIRIN 81MG ENTERIC COATED  DELAYED RELEASE
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-405
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDRIDE (UNII: 23J3BHR95O)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code HEART
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-405-401 in 1 CARTON12/15/2021
140 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69168-405-17300 in 1 BOTTLE; Type 0: Not a Combination Product12/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/15/2021
Labeler - Allegiant Health (079501930)

Revised: 11/2021
Document Id: 45839c39-884d-4298-8cdc-8fd596059613
Set id: d6c7c8c9-b997-4acc-a066-133bfb1239cb
Version: 4
Effective Time: 20211102
 
Allegiant Health