FDA label 8d6ed3ad-fd3f-47f3-e053-2995a90aba28

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
8d6edcac-504b-d437-e053-2995a90a6b7a
SPL ID
8d6ed3ad-fd3f-47f3-e053-2995a90aba28
Version
1
Effective date
2019-07-11
Source export date
2026-08-01
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/f23e8214fa581dc87bce024b3f15739356a8bb6f9298e3d6be38c21c662a4211/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:06:13

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 6 caplets 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 allergic 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 have 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 gets worse or lasts more than 3 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.