FDA label 23007611-e51a-4f28-b3e9-66ab545a5ced

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
e7af7a8d-8a64-42ff-a120-114fb9451ee3
SPL ID
23007611-e51a-4f28-b3e9-66ab545a5ced
Version
5
Effective date
2017-12-26
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:59:39

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.