FDA label f40489a9-8067-4e79-8b25-ce9683917630

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)

SPL set ID
108a2bc2-7960-4be3-8671-577a4ed1d1bd
SPL ID
f40489a9-8067-4e79-8b25-ce9683917630
Version
3
Effective date
2019-09-09
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:03

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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 captabs in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks everyday while using this product. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • with any other drug containing diphenhydramine, even one used on skin • in children under 12 years of age Ask a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are. • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • marked drowsiness will occur • avoid alcoholic drinks • alcohol, sedatives and tranquilizers may increase drowsiness • do not drive motor vehicle or operate machinery Stop use and ask a doctor if • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • sleeplessness lasts more than 2 weeks. Insomnia may be a sign of serious underlying medical illness. If pregnant or breast feeding, ask a health professional before use. Keep out of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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