The following Structured Product Label (SPL) was submitted to the FDA by Ncs Healthcare Of Ky, Llc Dba Vangard Labs for the product Adult Low Dose Aspirin (NDC 0615-8613). 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 do not use if imprinted safety seal under cap is broken or missing., uses, warnings, do not use, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID)*..................................Pain reliever
*nonsteroidal anti-inflammatory drug
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:
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other information
Colloidal silicon dioxide, croscarmellose sodium, D&C yellow 10, iron oxide yellow 6, lactose, methacrylic acid and ethyl acrylate copolymer,
microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate
* Please review the disclaimer below.
