acetaminophen pain reliever fever reducer

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 pain reliever fever reducer
Generic name
ACETAMINOPHEN
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Product type
HUMAN OTC DRUG
SPL set ID
b43974c3-4db9-4201-beee-b22596a2b241
SPL ID
4926c350-ee6f-446c-a63d-cc7170f9a68c
Version
7
Effective date
2025-02-12
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:19:18
Harmonized routes table
Harmonized routes
RECTAL

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 • an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • an adult takes 3 or more alcoholic drinks every day while using this product 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. For rectal use only Do not use • in children under 12 years • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if • you have liver disease • you are taking the blood thinning drug warfarin Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs. • pain gets worse or lasts more than 10 days. • new symptoms occur. • redness or swelling is present in the painful area. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and 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.