Label: EXTRA STRENGTH ACETAMINOPHEN- 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 April 20, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient Drug Facts

  • ASK DOCTOR

    Ask a Doctor Drug Facts

  • ASK DOCTOR/PHARMACIST

    Ask a Doc or Pharm Drug Facts

  • DO NOT USE

    Do not Use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach

  • PREGNANCY OR BREAST FEEDING

    Pregnant

  • PURPOSE

    Purpose

  • QUESTIONS

    Questions

  • STOP USE

    Stop Use

  • WHEN USING

    Directions

  • WARNINGS

    Warnings

  • STORAGE AND HANDLING

    Other Information

  • INACTIVE INGREDIENT

    Inactives

  • INDICATIONS & USAGE

    Uses

  • DOSAGE & ADMINISTRATION

    Uses:
    ■ temporarily relieves minor aches and pains due to:
    ■ the common cold ■ headache ■backache
    ■ minor pain of arthritis ■ toothache ■ muscular aches
    ■ premenstrual and menstrual cramps
    ■ temporarily reduces fever

  • PRINCIPAL DISPLAY PANEL

    Front Label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69732-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeCAPSULESize18mm
    FlavorImprint Code HTP500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69732-001-0130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/30/2020
    Labeler - Hi-Tech Nutraceuticals, LLC (606221443)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Techn Nutraceutical, LLC080787135pack(69732-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Nutraceuticals, LLC606221443manufacture(69732-001)
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!