FDA label a4cea968-5b65-4243-97db-9a03db4b76d1

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
07bc516b-3605-49cc-a56a-c7478f61322b
SPL ID
a4cea968-5b65-4243-97db-9a03db4b76d1
Version
2
Effective date
2017-08-09
Source export date
2026-10-12
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/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:36

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

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 daily maximum amount With other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Overdose warning: Taking more than the recommended done (overdose) may cause liver damage . In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. 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 other products containing diphenhydramine, even one used on skin Ask a doctor before use if you have : liver disease, asthma, breathing problems such as emphysema or chronic bronchitis, glaucoma, or difficulty in urinating due to an enlargement of the prostate gland. Ask a doctor or pharmacist before use if you are : taking sedatives or tranquilzers, or taking the blood thinning drug warfin When using this product: Avoid alcoholic beverages, do not drive a motor vehicle or operate machinery. This product will cause drowsiness. Stop use and ask a doctor if: Sleepiness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. Pain gets worse or last for more than 10 days Fever gets worse or lasts for more than 3 days New symptoms occur Redness or swelling is present If pregnant or breast-feeding, ask a health care 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.