FDA label 6a70eacf-aecb-73f5-e053-2a91aa0a5daf

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
6a70eac1-9947-80a8-e053-2991aa0abfde
SPL ID
6a70eacf-aecb-73f5-e053-2a91aa0a5daf
Version
1
Effective date
2018-04-22
Source export date
2026-08-08
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/e78f1fb32bf83ef6e9a19dc8cb100566f7817d0ac9ed04e609562ab8ed7ab1de/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:49:45

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 8 tablets 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 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 in this product 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 and ask doctor before use if: Pain gets worse or lasts more than 10 days. Fever gets worse or lasts more than 3 days. New symptoms occur. Redness or swelling is present. These could be signs of a serious condition. If pregant or breast-feeding, ask doctor before use. Keep out of reach of children. Directions do not take more than directed (see overdose warning). Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor. Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.