Adwe Feverx Acetaminophen Caplets, 500 mg 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: Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength
Generic name: ACETAMINOPHEN
Manufacturer: Aurex Laboratories Limited Liability Company
Product type: HUMAN OTC DRUG
SPL set ID: 948c5826-6f35-484d-bb3f-cecf6a4b5c13
SPL ID: 31a5e50a-d3b9-f512-e063-6394a90a8c10
Version: 6
Effective date: 2025-03-31
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:11:07

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		Aurex Laboratories Limited Liability Company	openfda.manufacturer_name
ndc	package	71009-109-01	openfda.package_ndc
ndc	product	71009-109	openfda.product_ndc
ndc11	package	71009010901	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
spl id		31a5e50a-d3b9-f512-e063-6394a90a8c10	id
spl set id		948c5826-6f35-484d-bb3f-cecf6a4b5c13	set_id
unii		362O9ITL9D	openfda.unii

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 warninig: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets in 24 hours. Severe liver damage may occur if you take: more than 8 caplets (4,000 mg of acetaminophen) in 24 hours 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 blisters rash If a skin 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. 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.

Reported adverse events (FAERS/openFDA)#

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