Other
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Enteric Coated Aspirin (NDC 70677-1122). 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 other, active ingredient (in each tablet), purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Aspirin 325 mg (NSAID)*
* nonsteroidal anti-inflammatory drug
Pain reliever
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.
Aspirin may cause a severe allergic reaction which may include:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Do not useif you are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor or pharmacist before use if you aretaking a prescription drug for:
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 right away (1-800-222-1222).
corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
Call 833-358-6431 Monday to Friday 9 am to 7 pm EST
* Please review the disclaimer below.