ASPIRIN- aspirin tablet, film coated 
KEM Pharma LLC

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Kem Pharma 44-157-NI

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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 

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

  • 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
  • an allergic reaction occurs. Seek medical help right away.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • any new symptoms occur

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

Other information

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol 

Principal Display Panel

Aspirin 325 mg
Pain Reliever/Fever Reducer (NSAID)

White Film Coated Tablets

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

CLOSE TIGHTLY TO OPEN PUSH DOWN AND TURN

This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin

50844     ORG091315712

Kem Pharma 44-157

Kem Pharma 44-157

ASPIRIN 
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60503-157
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;157
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60503-157-12100 in 1 BOTTLE; Type 0: Not a Combination Product02/10/1996
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only02/10/1996
Labeler - KEM Pharma LLC (079090402)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(60503-157)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(60503-157)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(60503-157)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(60503-157)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(60503-157)

Revised: 8/2023
Document Id: 80db3b23-d04f-4e37-968b-445245846572
Set id: 18e00303-9db1-4f70-a4f1-8b590fa959d7
Version: 12
Effective Time: 20230807
 
KEM Pharma LLC