FDA label 9aaef15c-5cc2-7d33-e053-2a95a90a0bdb

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
722242ce-d4aa-4eff-8179-5437405bad57
SPL ID
9aaef15c-5cc2-7d33-e053-2a95a90a0bdb
Version
2
Effective date
2019-12-27
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:11:49

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 with this product if you take more than 2 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while you are using this product Do not use with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist in children under 12 years of age with any other products containing diphenhydramine, even one used on skin if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver cirrhosis asthma breathing problems such as emphysema or chronic bronchitis trouble in urinating due to an enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness pain gets worse or lasts for more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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