NOTTS - Extra Strength 500 mg

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)

Brand name
NOTTS - Extra Strength 500 mg
Generic name
ACETAMINOPHEN
Manufacturer
VIVUNT PHARMA LLC
Product type
HUMAN OTC DRUG
SPL set ID
e677f43d-b4ce-e5b0-e053-2a95a90ad67e
SPL ID
2df54d96-b18b-e9e3-e063-6294a90a6926
Version
12
Effective date
2025-02-12
Source export date
2026-10-27
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 19:42:08
Harmonized routes table
Harmonized routes
ORAL

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 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen. 3 or more alcoholic drinks every day while using this product. Allergy Alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening rash blisters If a skin reaction occurs, stop use and seek medical attention immediately. 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 are allergic to acetaminophen or any of the inactive ingredients. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain lasts more than 10 days fever lasts more than 3 days pain or fever gets worse 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. Overdose warning Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. 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.