Aspirin 81mg Enteric Coated

openFDA label record#

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

Brand name
Aspirin 81mg Enteric Coated
Generic name
ASPIRIN
Manufacturer
HHH Pharmaceuticals
Product type
HUMAN OTC DRUG
SPL set ID
d81aec73-c7c1-4c52-80f6-fb0e32caf7aa
SPL ID
511f455b-cb98-e38f-e063-6394a90a24af
Version
2
Effective date
2026-05-06
Source export date
2026-08-01
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:34:10
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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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 shock facial swelling asthma (wheezing) 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 Ask a doctor before use if you have asthma 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 Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis under a doctor's care for any serious condition taking any other drug Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling present in the painful area new symptoms occur These could be sign of a serious condition If pregnant or breast-feeding, 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 (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.