Childrens Aspirin

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Childrens Aspirin
Generic name
ASPIRIN
Manufacturer
Cardinal Health 107, LLC
Product type
HUMAN OTC DRUG
SPL set ID
9200823a-5946-49e8-844e-a39061528e3e
SPL ID
1c205d92-a87f-4873-a746-a47a00203c07
Version
8
Effective date
2026-05-22
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:44:12
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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 hives, facial swelling, asthma (wheezing), shock. Stomach Bleeding Warning: This product contains an 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 -this product for at least 7 days after tonsillectomy or oral surgery unless directed by doctor. Ask a doctor before use if -stomach bleeding warning applies to you -you have a history of stomach problems, such as heartburn -you have high blood pressure, heart disease, liver cirrhosis, or kidney disease -you are taking a diuretic -you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for ·gout ·diabetes ·arthritis Stop use and ask a doctor if ·an allergic reaction occurs. Seek medical help right away ·you experience any of the following signs of stomach bleeding ; feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better ·pain gets worse or lasts for more than 10 days ·redness or swelling is present ·new symptoms occur ·ringing in the ears or loss of hearing occurs · You may report side effects to 1-888-952-0050. 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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery .

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.