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 Top Care (topco Associates Llc) for the product Aspirin (NDC 36800-968). 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
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 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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
D&C yellow #10, FD&C yellow #6, methacrylic acid copolymer, microcrystalline cellulose, pregelatinized starch (corn), silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triethyl citrate
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COMPARE TO BAYER® LOW DOSE ASPIRIN ACTIVE INGREDIENT†
LOW DOSE ASPIRIN REGIMEN††
Aspirin 81 mg
PAIN RELIEVER (NSAID)
Safety-Coated
ENTERIC COATED TABLETS
††Talk to your doctor or other healthcare provider before using this product for your heart. Aspirin is not right for everyone
≠Coating helps protect against stomach upset
†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
* Please review the disclaimer below.