Exaprin Plus

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
Exaprin Plus
Generic name
ASPIRIN, ACETAMINOPHEN, CAFFEINE
Manufacturer
HART Health
Product type
HUMAN OTC DRUG
SPL set ID
8a9ca680-e6cf-4ee4-8a5f-bd6d7470b848
SPL ID
c3b1d504-cbf3-4d95-aa12-ee5c70733b6c
Version
1
Effective date
2025-08-04
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:34:06
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

Warning Reye’s syndrome : Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with asprin. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Allergy alert: Acetaminophen may cause severe skin reactions which may include: rash blisters skin reddening Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day while using this product 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 more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor before use if you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have a history of stomach problems, such as heartburn stomach bleeding warning applies you Ask a doctor or pharmacist before use if you take any drug for diabetes, gout, or arthritis take any drug containing an NSAID you do not know if other drugs you are taking contain acetaminophen Stop use and ask a doctor if an allergic reaction occurs, seek medical help right away new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs fever gets worse or lasts more than 3 days pain gets worse or lasts more than 10 days you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better. 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 at 20 weeks or later in 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. Overdose warning taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adult as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Reported adverse events (FAERS/openFDA)#

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