FDA label 45d32473-7a94-266d-e063-6394a90a4810

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
e2308622-0b91-3cb4-e053-2a95a90a6149
SPL ID
45d32473-7a94-266d-e063-6394a90a4810
Version
4
Effective date
2025-12-13
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:31:49

Boxed warning cross-check#

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boxed warning

Caution: Do not use if imprinted seal under cap is broken or missing

Warnings cross-check#

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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 6 tablets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin or severe allergy reactions. Symptoms may include: Skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin or general allergic reaction occurs, stop use and seek medical help right away 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. If you ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have: liver disease glaucoma difficulty in urination due to enlargement of the 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 you may get drowsy avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee. Stop use and ask a doctor if: new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever get worse or lasts more than 3 days If pregnant or breast feeding, ask a health care professional before use. Overdose warning In case of overdose, get medical help or contact a poison control center 1-800-222-1222 right away. Quick medical help attention is critical for adults as well as 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.