Active Ingredient (In Each Tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Aspirin Regimen (NDC 70000-0604). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever
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.
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
taking a prescription drug for
These could be signs of a serious condition.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
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
1-800-426-9391
LEADER™
NDC 70000-0604-2
Low Dose | Safety Coated
Aspirin Regimen**
Delayed Release, 81 mg | Pain Reliever (NSAID)
**Talk to Your Doctor or Other
Healthcare Provider before Using
This Product for Your Heart.
COMPARE TO
ST. JOSEPH®
LOW DOSE ASPIRIN
active ingredient*
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120 ENTERIC COATED
TABLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 ORG012264532
*This product is not manufactured or distributed by
Foundation Consumer Healthcare, LLC, owner of the
registered trademark St. Joseph® Low Dose Aspirin.
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.
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