FDA.reportPublic FDA data

Adwe Feverx Acetaminophen Caplets, 500 mg

Manufacturer
Aurex Laboratories Limited Liability Company | Adwe Products & Imports Inc.
Effective date
2025-03-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:58:18

Label at a glance#

ProductAdwe Feverx Acetaminophen Caplets, 500 mg Extra Strength
Active ingredientACETAMINOPHEN
Label structure12 sections

Storage and handling

Other information Store at 20° C - 25° C (68° F - 77° F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Acetaminophen 500 mg

OTC - PURPOSE SECTION

Uses:

  • temporarily relives minor aches and pains
  • temporarily reduces fever

INDICATIONS & USAGE SECTION

Minor aches and pains, fever.

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

Stop use and ask a doctor 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • do not take more than directed
  • adults and children 12 years and over: take 1-2 caplets every 4-6 hours, as needed. Do not take more than 6 caplets in 24 hours, unless directed by a doctor.
  • children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • Store at 20° C - 25° C (68° F - 77° F)

INACTIVE INGREDIENT SECTION

Inactive ingredients:

microcrystalline cellulose, vegetable magnesium stearate. May contain povidone.

HOW SUPPLIED SECTION

* This product is not manufactured or distributed by the owner of the registered trademark TYLENOL ®.

Distributed By:

Adwe Laboratories

1274 49 St. Brooklyn, NY 11219

This product contains no animal, soybean, or grain derivatives.

This product does not contain any Chometx or Krtnius.

REV 0221

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN6
198440acetaminophen 500 MG Oral TabletSCD6
198440APAP 500 MG Oral TabletSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71009-109-012024-12-23C16284748780-1f386c649-c0c3-0266-e053-dadaa90a7c1aAdwe Feverx Acetaminophen Caplets, 500 mg
71009-109-012023-01-30C16284748780-1f386c649-c0c3-0266-e053-dadaa90a7c1aAdwe Feverx Acetaminophen Caplets, 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71009-109-01Adwe Feverx Acetaminophen Caplets, 500 mgExtra Strength100 in 1 BOTTLETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71009-109ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH (ACETAMINOPHEN) TABLET [AUREX LABORATORIES LIMITED LIABILITY COMPANY]6Current NDC, Legacy NDC, 1 package rows20250402_948c5826-6f35-484d-bb3f-cecf6a4b5c13.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71009-10971009-109-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
POVIDONEFZ989GH94EIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthACETAMINOPHENAurex Laboratories Limited Liability Company948c5826-6f35-484d-bb3f-cecf6a4b5c132025-03-31WarningsExact identifier
ndc (package): 71009-109-01
ndc (product): 71009-109
ndc11 (package): 71009010901
spl id: 31a5e50a-d3b9-f512-e063-6394a90a8c10
spl set id: 948c5826-6f35-484d-bb3f-cecf6a4b5c13

Reported adverse events (FAERS/openFDA)#

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