ASPIRIN REGIMEN- aspirin tablet, delayed release

Aspirin Regimen by

Drug Labeling and Warnings

Aspirin Regimen by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. DBA Leader, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• hives
• facial swelling
• shock
• asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older
• take more or for a longer time than directed
• have 3 or more alcoholic drinks every day while using this product
• have had stomach ulcers or bleeding problems
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  

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 are taking a diuretic
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• 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
• fever gets worse or lasts more than 3 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 at 20 weeks or later in 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 right away.

Directions

• do not take more than directed
• 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: do not use unless directed by a doctor
  

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number
  

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: 70000-0604-1

Low Dose | Safety Coated
Aspirin Regimen**
Delayed Release, 81 mg | Pain Reliever (NSAID)

COMPARE TO
ST. JOSEPH®
LOW DOSE ASPIRIN
active ingredient†

100% Money Back Guarantee

36 ENTERIC COATED
TABLETS

Actual Size

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 Aspirin.
50844 REV0122A64507

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

©2022 Cardinal Health. All Rights Reserved. CARDINAL
HEALTH, the Cardinal Health LOGO, LEADER, and the
Leader LOGO are trademarks or registered trademarks
of Cardinal Health. All other marks are the property of
their respective owners.

Leader 44-645

INGREDIENTS AND APPEARANCE

ASPIRIN REGIMEN 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0604
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	L
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0604-1	1 in 1 CARTON	06/01/2022
1		36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 70000-0604-2	1 in 1 CARTON	06/01/2022
2		120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	06/01/2022

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(70000-0604)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(70000-0604)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(70000-0604)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	manufacture(70000-0604)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(70000-0604)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(70000-0604)