Label: ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH- 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 March 8, 2021

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient: Acetaminophen 500 mg

  • PURPOSE

    Uses:

    • temporarily relives minor aches and pains
    • temporarily reduces fever
  • INDICATIONS & USAGE

    Minor aches and pains, fever.

  • 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.

  • WHEN USING

    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.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    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

    Other information

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

    Inactive ingredients:

    microcrystalline cellulose, vegetable magnesium stearate. May contain povidone.

  • HOW SUPPLIED

    * 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

  • PRINCIPAL DISPLAY PANEL

    Label
  • INGREDIENTS AND APPEARANCE
    ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71009-109
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code A;A2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71009-109-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/09/2021
    Labeler - Aurex Laboratories Limited Liability Company (067585317)
    Registrant - Adwe Products & Imports Inc. (080081765)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurex Laboratories Limited Liability Company067585317MANUFACTURE(71009-109)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geri-Care Pharmaceuticals, Corp038883275REPACK(71009-109)
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!