FDA.reportPublic FDA data

ACETAMINOPHEN 500 MG TABLET

Manufacturer
Syntho Pharmaceuticals, Inc.
Effective date
2020-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:16

Label at a glance#

ProductAdwe Feverx
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning) adults & children 12 years and over: take 1-2 tablets every 4-6 hours as needed do not take more than 6 tablets in 24 hours children under 12 years: do not use

Storage and handling

​TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store at 20ºC - 25ºC (68ºF - 77ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg (8 tablets) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Overdose Warning

OVERDOSAGE SECTION

Taking more than therecommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact Poison Control Centre right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see overdose warning)

adults & children 12 years and over:

  • take 1-2 tablets every 4-6 hours as needed
  • do not take more than 6 tablets in 24 hours

children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

​TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

  • store at 20ºC - 25ºC (68ºF - 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone. May also contain: cellulose, croscarmellose sodium, magnesium silicate, silica, vegetable magnesium starate

SPL UNCLASSIFIED SECTION

* This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®. This products contain no animal, soybean or grain derivatives. THis product does not contains any Chometz or Kitnius.

​KOSHER FOR PASSOVER

DIST BY: Adwe Laboratories

1274 49 St. Brooklyn, NY 11219

REV 201-0415

​PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 666576-200-01

KOSHER FOR PASSOVER

Adwe Feverx

Acetaminophen Tablets

PAIN RELIEVER FEVER REDUCER

EXTRA STRENGTH TABLETS

Compare to Active Ingredient in Extra Strength Tylenol®*

100 TABLETS 500 mg each

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66576-200-012022-01-28C16284748780-1d6a99b39-4081-a426-e053-dadaa90af4c2ACETAMINOPHEN 500 MG TABLET

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66576-200-01Adwe Feverx100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66576-200ADWE FEVERX (ACETAMINOPHEN) TABLET [SYNTHO PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20200612_5274ce51-13df-4c2a-b467-e34ea8fdc1e3.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66576-20066576-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
POVIDONEFZ989GH94EIACT
POWDERED CELLULOSESMD1X3XO9MIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM SILICATE9B9691B2N9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT

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
66af09f4-1566-4f1e-9cde-3eaf5eea27565274ce51-13df-4c2a-b467-e34ea8fdc1e32020-02-04WarningsExact identifier
spl id: 66af09f4-1566-4f1e-9cde-3eaf5eea2756
spl set id: 5274ce51-13df-4c2a-b467-e34ea8fdc1e3

Reported adverse events (FAERS/openFDA)#

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