ASPIRIN ENTERIC COATED- aspirin 81 mg tablet 
Allegiant Health

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Drug Facts

Active ingredient

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

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains 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 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 ulcers 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 have ever had an allergic reaction to 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

are taking a prescription drug for  

  • 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

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 PoisonControl 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

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

Questions and Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Package/Label Principal Display Panel

Aspirin

Aspirin

ASPIRIN  ENTERIC COATED
aspirin 81 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-372
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 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
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:69168-372-501 in 1 CARTON11/11/2020
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69168-372-061 in 1 CARTON11/11/2020
2120 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69168-372-17300 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2020
4NDC:69168-372-401 in 1 CARTON02/03/2022
440 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:69168-372-99365 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/11/2020
Labeler - Allegiant Health (079501930)

Revised: 11/2020
Document Id: bdee154f-072f-4735-8fed-8cc46e08dc1f
Set id: 8cacf02c-9925-40d4-92bc-78788aa0681a
Version: 6
Effective Time: 20201111
 
Allegiant Health