Label: ADWE FEVERX- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 4, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    • temporarily relieves minor aches and pains
    • temporarily reduces fever
  • Warnings

    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

    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 blood thinning drug warfarin

    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.

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children

    Overdose Warning

    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

    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

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

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

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

  • Questions or comments

  • 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

    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

    Label

  • INGREDIENTS AND APPEARANCE
    ADWE FEVERX 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66576-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66576-200-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/04/2020
    Labeler - Syntho Pharmaceuticals, Inc. (088797407)
    Registrant - Syntho Pharmaceuticals, Inc. (088797407)
    Establishment
    NameAddressID/FEIBusiness Operations
    Syntho Pharmaceuticals, Inc.088797407manufacture(66576-200)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!