ADULT ASPIRIN REGIMEN LOW DOSE- aspirin tablet, delayed release 
Cardinal Health 110, LLC. DBA Leader

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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Leader 44-645-Delisted

Active ingredient (in each tablet)

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:

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 you are

taking a prescription drug for

  • gout
  • diabetes
  • 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:
    • vomit blood
    • have bloody or black stools
    • feel faint
    • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition. 

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

colloidal anhydrous silica, corn starch, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate 

Questions or comments?

1-800-426-9391 

Principal Display Panel

LEADER™

NDC 70000-0218-1

Low Dose | Safety Coated

Adult Aspirin Regimen**
Delayed Release, 81 mg | Pain Reliever (NSAID)

36
ENTERIC
COATED TABLETS       ACTUAL SIZE

COMPARE TO ST. JOSEPH® LOW DOSE SAFETY COATED 81 mg ASPIRIN active ingredient†

100% Money Back Guarantee

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

**Talk to your doctor or other healthcare provider before using this product for your heart.

†This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, owner of the registered trademark St. Joseph® Low Dose Safety Coated 81 mg Aspirin.

50844   REV0318A64507

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com   1-800-200-6313

CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

100% Money Back Guarantee
Return to place of purchase if not satisfied.

Leader 44-645

Leader 44-645

ADULT ASPIRIN REGIMEN  LOW DOSE
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0218
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize6mm
FlavorImprint Code L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0218-11 in 1 CARTON07/25/201410/11/2024
136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:70000-0218-21 in 1 CARTON07/25/201410/11/2024
2120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/25/201410/11/2024
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(70000-0218)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(70000-0218)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(70000-0218)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(70000-0218)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(70000-0218)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(70000-0218)

Revised: 7/2023
Document Id: b9fe5739-9b0c-44d0-9785-d70b7c2da122
Set id: 9829f56f-723c-473f-89ee-4cb2efb3b8bc
Version: 10
Effective Time: 20230720
 
Cardinal Health 110, LLC. DBA Leader