ASPIRIN 81 MG ENTERIC COATED- aspirin tablet 
Marlex 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 81mg Enteric Coated Tablets

ASPIRIN 81MG TABLETS

Marlex Pharmaceuticals, Inc.

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Active ingredient (in each tablet)

Purpose

Drug Fact
Active ingredient (in each tablet) Purpose
 Aspirin 81mg (NSAID*)…………………………………………Pain Reliever
*nonsteroidal anti-inflammatory drug

Aspirin 81 mg Tablets

Uses

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

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
  • You have not been drinking fluids
  • You have lost a lot of fluid due to vomiting or diarrhea

Ask a doctor or a pharmacist before use if you are

  • Taking a prescription drug for diabetes, gout, or arthritis
  • Under a doctor’s care for any serious condition
  • Taking any other drug

Stop use and ask a doctor if

  • You experience any of the following signs of stomach bleeding
  • Feel faint
  • Have bloody or black stools
  • Vomit blood
  • Have stomach pain that does not get better
  • Pain gets worse or lasts more than 10 days
  • Redness or swelling is present in the painful area
  • Any new symptoms appear
  • 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 problem 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 right away.

Directions:

Other Information:

Inactive Ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized Starch, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl Acrylate Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6

Questions?

Adverse Drug Event Call: (800) 222-1222

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 12/19 HP

PRINCIPAL DISPLAY PANEL

ASPIRIN
81mg
120 Tablets

PRINCIPAL DISPLAY PANEL
ASPIRIN
81mg
120 Tablets

ASPIRIN 81 MG ENTERIC COATED 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-689
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize5mm
FlavorImprint Code A1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-689-62120 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/01/2020
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 9/2021
Document Id: ccb224b8-342b-19f3-e053-2a95a90a7d91
Set id: e35ebda4-aff9-4870-81e2-85b85e5c4db1
Version: 4
Effective Time: 20210923
 
Marlex Pharmaceuticals Inc