Active Ingredients (In Each Tablet)
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Aspirin 81 Mg Enteric Coated (NDC 69618-046). 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 ingredients (in each tablet), purpose, uses, warnings, other safety information, other, otc - do not use, otc - ask doctor, 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
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 symptons could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which any include:
Stomach bleeding warning: This product contains NSAID, which may cause severe stomach bleeding. The chance is higher if you:
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if
Stop use and ask a doctor if
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
These could be sings of a serious condition.
If pregnant or brest-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 conplications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate
call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
NDC 69618-046-10
Enteric Coated
Aspirin USP 81mg (NSAID
Adult Low Strength
PAIN RELIEVER
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
1000 TABLETS
* Please review the disclaimer below.