FDA.reportPublic FDA data

Acetaminophen Extra Strength

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
Acetaminophen Extra Strength
Generic name
ACETAMINOPHEN
Manufacturer
Dr. Reddy's Laboratories Inc.
Product type
HUMAN OTC DRUG
SPL set ID
9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f
SPL ID
2430c250-51a4-2fd4-5eb9-352bf8734bbb
Version
2
Effective date
2026-07-15
Source export date
2026-10-30
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-30/a3e33fe073aa0aa94eb690c6684c74434c63cebfbf7c5530205a2c3e957ecb8b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run
20261102T182004Z
Imported at
2026-11-02 19:43:24
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 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 with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

warnings

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away

Reported adverse events (FAERS/openFDA)#

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